NDPS Act 1985 with Rules 1985-Authorities and Officials-

Authorities and Officials-

(A) Measures to Prevent and Combat Narcotic Drug Abuse and Illicit Trafficking:

The Central Government, as stipulated by this legislation, is empowered to undertake various actions related to the enforcement of this Act and other relevant laws. These actions include:

1. Coordinating actions among different officers, State Governments, and relevant authorities involved in enforcing this Act or other existing laws concerning the enforcement of its provisions.
2. Fulfilling obligations under International Conventions.
3. Providing assistance to foreign authorities and relevant international organizations in preventing and suppressing illicit trafficking of narcotic drugs and psychotropic substances.
4. Addressing the identification, treatment, education, aftercare, rehabilitation, and social reintegration of addicts.
5. Addressing any other matters necessary for the effective implementation of this Act and for preventing and combatting the abuse of narcotic drugs, psychotropic substances, and illicit trafficking.

(B) Central Government Officers:

Under the provisions of this Act, the Central Government is authorized to appoint a Narcotic Commissioner and other officers as deemed necessary. The Narcotic Commissioner, either independently or with the assistance of other officers, shall carry out functions related to:
(i) Supervising the cultivation of opium poppy;
(ii) Overseeing the production of opium; and
(iii) Handling other functions as delegated by the Central Government.

State Governments may appoint suitable officers for the purposes of this Act.

(C) The Narcotic Drugs and Psychotropic Substances Consultative Committee:

To ensure efficient administration of this Act, the Central Government may establish an advisory committee named "The Narcotic Drugs and Psychotropic Substances Consultative Committee." This committee shall consist of a Chairman and up to 20 other members appointed by the Central Government. For effective functioning, the Committee may establish one or more sub-committees. The committee's role is to provide advice to the Central Government on matters concerning the administration of this Act.

(D) Prohibition, Control, and Regulation:

Section 8 of this Act prohibits specific operations, such as the cultivation of coca plants, opium, and cannabis plants, as well as the manufacture, possession, sale, purchase, transport, import, export, etc., of narcotic drugs and psychotropic substances, except for medical and scientific purposes. However, section 9 of this Act grants the Central Government the authority to permit, control, and regulate certain operations concerning these substances through rules.

(a) Prohibition of Specific Operations as per Section 8:

(i) Cultivating any coca plant or harvesting any part of a coca plant;
(ii) Cultivating opium poppy or any cannabis plant;
(iii) Producing, manufacturing, possessing, selling, purchasing, transporting, warehousing, using, consuming, importing interstate, exporting interstate, importing into India, exporting from India, or transshipping any narcotic drug or psychotropic substance, except for medical and scientific purposes and in accordance with the provisions of this Act, or the rules or orders issued under it.

(b) Power of Central Government to Permit, Control, and Regulate:

1. Permission and Regulation of Specific Operations by Central Government:
(i) Regulating the cultivation or harvesting of coca plants (only under the Central Government's authority) or the production, sale, purchase, transport, interstate import, interstate export, use, or consumption of coca leaves.
(ii) Controlling the cultivation of opium poppy (only under the Central Government's authority).
(iii) Managing the production and manufacture of opium and opium straw.
(iv) Authorizing the sale of opium and opium derivatives from Central Government factories for export from India or sale to State Governments or manufacturing chemists.
(v) Regulating the manufacture of manufactured drugs (excluding prepared opium), but not including the manufacture of medicinal opium or any preparation containing any manufactured drug from legally possessed materials.
(vi) Overseeing the manufacture, possession, transport, interstate import, interstate export, sale, purchase, consumption, or use of psychotropic substances.
(vii) Managing the import into India, export from India, and transshipment of narcotic drugs and psychotropic substances.

2. Control of Specific Operations by the Central Government:
(i) Establishing limits within which licenses may be granted for the cultivation of opium poppy.
(ii) Requiring cultivators to deliver all opium, the product of land cultivated with opium poppy, to authorized officers acting on behalf of the Central Government.
(iii) Empowering the Central Government to determine the price to be paid to cultivators for the delivered opium.
(iv) Specifying the forms and conditions of licenses or permits for the manufacture, possession, transport, interstate import, interstate export, sale, purchase, consumption, or use of psychotropic substances. The rules may also prescribe the relevant authorities and associated fees.
(v) Specifying the forms and conditions of licenses for the cultivation of opium poppy and the production and manufacture of opium. The rules may also outline the applicable fees, the authorities responsible for granting, withholding, refusing, or canceling such licenses, and the avenues for appealing decisions to withhold, refuse, or cancel licenses.
(vi) Mandating the weighing, examination, and classification of opium by officers authorized by the Central Government in the presence of the cultivator at the time of delivery.
(vii) Providing for the weighing, examination, and classification of received opium at the factory according to its quality and consistency, and adjusting the standard price based on the examination results.
(viii) Specifying the forms and conditions of licenses for the manufacture of manufactured drugs, along with the authorities authorized to grant such licenses and the associated fees.
(ix) Allowing for the confiscation of adulterated opium delivered by a cultivator, as determined through examination at a Central Government factory.
(x) Prescribing the ports and other locations where narcotic drugs or psychotropic substances may be imported into India, exported from India, or transshipped. The rules may also stipulate the forms and conditions of certification, authorizations, or permits, the relevant authorities for granting such certificates, authorizations, or permits, and the applicable fees.

Power of State Government to Permit, Control, and Regulate:

1. Permission and Regulation of Specific Operations by State Government:

(i) Regulating the possession, transport, interstate import, interstate export, warehousing, sale, purchase, consumption, and use of poppy straw.
(ii) Regulating the possession, transport, interstate import, interstate export, sale, purchase, consumption, and use of opium.
(iii) Controlling the cultivation of any cannabis plant and the production, manufacture, possession, transport, interstate import, interstate export, sale, purchase, consumption, or use of cannabis (excluding charas).
(iv) Overseeing the manufacture of medicinal opium or any preparation containing any manufactured drug from materials lawfully possessed by the maker.
(v) Regulating the possession, transport, purchase, sale, interstate import, interstate export, use, or consumption of manufactured drugs other than prepared opium, coca-leaf, and any preparation containing any manufactured drug.
(vi) Managing the manufacture and possession of prepared opium from opium lawfully possessed by an addict registered with the State Government for personal consumption based on medical advice.

2. Control of Specific Operations by State Government:

(i) Establishing limits within which licenses may be granted for the cultivation of any cannabis plant.
(ii) Restricting cultivation of any cannabis plant to cultivators licensed by the prescribed authority of the State Government.
(iii) Mandating that all cannabis, the product of land cultivated with cannabis plants, be delivered by cultivators to officers of the State Government authorized for this purpose.

(iv) Empowering the State Government to determine the price to be paid to cultivators for the delivered cannabis.
(v) Specifying the forms and conditions of licenses or permits for the possession, transport, interstate import, interstate export, warehousing, sale, purchase, consumption, and use of poppy straw, opium, and cannabis (excluding charas).

 The Narcotic Drugs and Psychotropic Substances Act 1985

Introduction and Objectives

The enactment of the Narcotic Drugs and Psychotropic Substances Act, 1985, marked a significant departure from outdated legislations like the Opium Act, 1857, the Opium Act, 1878, and the Dangerous Drugs Act, 1930. Recognizing the evolving landscape of illicit drug trade and drug abuse at both national and international levels, it became evident that these earlier Acts had several shortcomings. Consequently, the Indian government recognized the pressing need to address these deficiencies and subsequently repealed the old Acts.

The Narcotic Drugs and Psychotropic Substances Act, 1985 was introduced to rectify the shortcomings of the previous legislations. This act incorporates stringent provisions aimed at prohibiting, controlling, and regulating various aspects related to Narcotic Drugs and Psychotropic Substances. It establishes a comprehensive licensing system for both Central and State Governments to govern the manufacture, cultivation, import, export, inter-state traffic, transportation, sale, possession, and related activities concerning Narcotic Drugs and Psychotropic Substances.

The principal objective of this act is to consolidate and amend the existing laws related to narcotic drugs, imposing stringent regulations for their control and management, and addressing associated matters.

Preventing Illicit Traffic in Narcotic Drugs and Psychotropic Substances Ordinance, 1988, was enacted to detain individuals in specific cases to prevent illicit drug trafficking and abuse, aligning with the broader objectives of the Narcotic Drugs and Psychotropic Substances Act, 1985.

Definitions

1. Addict:

An individual habituated to the regular use of any narcotic drug or psychotropic substance is referred to as an Addict.

2. Cannabis (Hemp):

This category encompasses:
(i) Charas: Resin in crude or purified form obtained from the cannabis plant, including concentrated preparations and resin known as hashish oil or liquid hashish.
(ii) Ganja: Flowering or fruiting tops of the cannabis plant (excluding seeds and leaves not accompanied by the tops).
(iii) Any mixture, with or without neutral material, of ganja or charas, or any drink prepared from them.

3. Coca Derivative:

Includes:
(i) Crude cocaine, usable directly or indirectly for the manufacture of cocaine.
(ii) Ecgonine and all its derivatives from which it can be recovered.
(iii) Cocaine: Methyl ester of benzoyl-ecogonine and its salts.
(iv) Preparations containing more than 0.1 per cent of cocaine.

4. Coca Leaf:

Comprises:
(a) The leaf of the coca (Erythroxylon) plant (excluding the leaf from which all ecgonine, cocaine, and any other ecgonine alkaloids have been removed).
(b) Any mixture thereof with or without any neutral material, excluding preparations containing less than 0.1% of cocaine.

5. Manufacture:

This term encompasses:
(i) All processes, excluding production, by which narcotic drugs or psychotropic substances may be obtained.
(ii) Refining or transformation of such drugs or substances.
(iii) Making preparations containing such drugs or substances.

6. Manufactured Drugs:

Include:
(a) All coca derivatives, medicinal cannabis, opium derivatives, and poppy straw concentrate.
(b) Any other narcotic substance or preparation which the Central Government may, based on available information regarding its nature or decisions under any International Convention, declare to be a manufactured drug.

7. Medicinal Cannabis (Medicinal Hemp):

Any extract or tincture of cannabis.

8. Narcotic Drug:

Encompasses coca leaf, cannabis (hemp), opium, and poppy straw, including all manufactured drugs.

9. Opium:

Refers to the coagulated juice of the opium poppy and its mixture with or without neutral material (excluding preparations containing less than 0.2 per cent of morphine).

10. Opium Derivative:

Inclusive of:
(i) Medicinal opium.
(ii) Prepared opium.
(iii) Phenanthrene alkaloids such as morphine, codeine, thebaine and their salts.
(iv) Diacetyl morphine (heroin) and its salts.
(v) All preparations containing more than 0.2% of morphine or any amount of diacetyl morphine.

11. Opium Poppy:

Includes the plant of Papaver somniferum and other species of Papaver from which opium or any phenanthrene alkaloid can be extracted.

12. Poppy Straw:

Encompasses all parts (except the seeds) of the opium poppy after harvesting, whether in original form or cut, crushed, or powdered, and whether or not juice has been extracted therefrom.

13. Psychotropic Substance:

Denotes any natural or synthetic substance or any salt or preparation of such substance or material, listed in the schedule of psychotropic substances.

14. Illicit Traffic (Supplement to the Narcotic Drugs Act, The Prevention of Illicit Traffic in Narcotic Drugs and Psychotropic Substances Ordinance, 1988):

Involves:
(i) Cultivating any coca plant or gathering any portion of the coca plant.
(ii) Cultivating the opium poppy or any cannabis plant.
(iii) Engaging in the production, manufacture, possession, sale, purchase, transportation, warehousing, concealment, use or consumption, interstate import, inter-state export, import into India, export from India or trans-shipment of narcotic drugs or psychotropic substances.
(iv) Dealing in narcotic drugs, psychotropic substances.
(v) Handling or letting any premises for use for any of the purposes referred to in (i) to (iv).
(vi) Financing any activity by oneself or through any other person in the furtherance or support of any of the aforementioned acts.
(vii) Harbouring persons engaged in any of the activities specified in (i) to (vi).
(viii) Abetting or conspiring in the furtherance or support of any of the aforementioned acts, except to the extent permitted under the Narcotic Drugs and Psychotropic Substances Act, 1985, or any rule or order made, or any condition of any license, permit, or authorization issued thereunder.

Drugs and Magic Remedies Act 1954 and Rules 1955

Categories of drugs and remedies that are exempted from the purview of this Act-

The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules 1955 is an Indian law enacted to control and prohibit the advertisement of certain drugs and remedies that claim to have magical or supernatural properties for the treatment of various ailments. The Act aims to prevent the spread of false or misleading advertisements related to drugs, which can be harmful to the public.

Under the Drugs and Magic Remedies Act, 1954, and its accompanying Rules, there are certain categories of drugs and remedies that are exempted from the purview of this Act. These exemptions are outlined in Section 3 of the Act and Rule 3 of the Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1955. Here is a brief overview of the exemptions:

1. Drugs and Remedies Prescribed by Registered Medical Practitioners: The Act does not apply to drugs or remedies that are prescribed by a registered medical practitioner. In other words, advertisements for medications or treatments recommended by qualified doctors are generally exempt from this law.
2. Drugs Listed in Approved Books: If a drug or remedy is listed in any of the books specified in the Schedule to the Act, then it is exempted. The Schedule typically includes recognized pharmacopoeias and authoritative reference books where the properties and uses of drugs are listed.
3. Drugs Approved by the Central Government: The Central Government has the authority to exempt certain drugs or classes of drugs from the provisions of the Act if it deems it necessary in the public interest.

It's important to note that while these exemptions exist, the Act is primarily aimed at curbing misleading or fraudulent advertisements for drugs and remedies that claim magical or supernatural properties. The Act also includes provisions to prevent the advertisement of drugs for the treatment of diseases and conditions that are not amenable to self-medication. 

Offences and Penalties:

The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, is a legislative framework enacted by the Indian government to regulate and prohibit the advertising of certain drugs and remedies that claim to possess magical or supernatural properties for the treatment of various illnesses. The primary aim of this act is to curb the dissemination of misleading or false advertisements related to drugs and remedies, which can be potentially harmful to the public.

The act outlines specific offences and penalties for contravention of its provisions and rules. According to Section 1 of the Act, any violation of its provisions or the accompanying rules can result in penalties as follows:

(a) First Conviction:

A person or entity found guilty of contravening any provision of the Act or its rules during the first conviction may face imprisonment for a period of up to six months, or a fine, or both, as determined by the competent authorities.

(b) Subsequent Convictions:

In the case of subsequent convictions, the penalty becomes more stringent. A person or entity found guilty of violating the Act during subsequent convictions may be subject to imprisonment for a term extending up to one year, or a fine, or both, as determined by the appropriate authorities.

The Act places considerable emphasis on ensuring compliance with its regulations and imposes penalties of varying degrees to deter potential offenders. It is essential for individuals, organizations, and companies involved in the production, distribution, or advertising of drugs and remedies to adhere to the provisions of this act to avoid legal repercussions. 

Miscellaneous:

In addition to specifying offences and penalties, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, contains miscellaneous provisions designed to further regulate drug advertisements and ensure compliance with the law.

(i) Scrutiny of Misleading Advertisements:

One crucial aspect of the Act involves the scrutiny of drug-related advertisements to identify misleading claims. The State Government authorizes specific individuals for this purpose. If an authorized person determines that an advertisement relating to a drug breaches the provisions of the Act, they may direct the manufacturer, packer, distributor, or seller of the drug to provide essential information regarding the drug's composition for scrutiny within a specified time frame.

It is the responsibility of the manufacturer, packer, distributor, or seller of the advertised drug to comply with this directive. Failure to do so is deemed an offense. Moreover, the Act shields publishers and advertising agencies from culpability unless they fail to comply with any directive issued by the relevant authority.

(ii) Confidential Transmission of Advertisements:

Another aspect of the Act deals with the confidential transmission of certain advertisements. Advertisements falling under exempted categories, as discussed in the Act, are to be sent by post to registered medical practitioners, wholesale or retail chemists. The document containing such advertisements must prominently display the words "For the use only of registered medical practitioner or hospital or a laboratory" in indelible ink, emphasizing the confidentiality and restriction on use to authorized personnel.

(iii) Obtaining Prior Government Approval for Advertisement Publication:

The Act necessitates obtaining prior government approval for the publication of advertisements falling under the exempted categories outlined in the legislation. To secure this approval, an individual must submit an application to the designated officer appointed by the Central or State Government. This application should provide crucial information, including the registered and trade names of the drug, detailed composition, and specific reasons justifying the need for government sanction.

The authorized officer then reviews and submits the application to the respective government for approval. This process ensures a thorough evaluation of advertisements claiming exemptions, promoting responsible advertising and safeguarding the interests of the public.

In conclusion, the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, is a significant legislation designed to regulate drug-related advertisements, prevent misleading claims, and ensure the responsible advertising of drugs and remedies. The act provides a framework of offences and penalties to deter violations while incorporating miscellaneous provisions to address specific aspects like advertisement scrutiny, confidential transmission, and government approval for select advertisements. Compliance with this act is vital to maintain the integrity of drug advertising and protect public health and safety.

DRUGS AND MAGIC REMEDIES ACT, 1954 AND RULES 1955: PURPOSE, PROHIBITED & EXEMPTED ADVERTISEMENTS

This legislation ( Drugs and magic remedies act,1954 and rules 1955) remains constitutionally valid as it does not unduly interfere with private enterprise and imposes reasonable restrictions.

The regulations outlined in this Act are supplementary and do not diminish the authority of any other existing laws.

PURPOSE

This act was enacted to:

(1) Regulate specific categories of advertisements pertaining to drugs, and

(2) Prohibit misleading advertisements regarding magic remedies that falsely claim miraculous properties,

(3) Address associated matters.

DEFINITIONS

1. Advertisement:

This encompasses:

(1) Any form of written or visual communication like notices, circulars, labels, or similar documents,

(2) Any oral announcements or signals such as light, sound, or smoke.

2. Magic Remedy:

This includes Talismans, Mantras, Kavachas, or any similar charm claiming extraordinary powers:

(a) For diagnosing, treating, or preventing diseases in humans or animals, or

(b) For affecting or altering the structure or organic function of the body or animal.

3. Drug:

This encompasses the following:
(1) Medicines for internal or external use for humans or animals,

(2) Substances intended for diagnosing, curing, mitigating, treating, or preventing diseases in humans or animals,

(3) Articles (excluding food) that affect or alter the structure or organic function of the human or animal body,

(4) Articles used as components of any medicine.

4. Registered Medical Practitioner:

Refers to any individual,

(i) Holding qualifications granted by authorities specified in, or notified under, Sec. 3 of the Indian Medical Degrees Act, 1916, or specified in the schedules to the Indian Medical Council Act, 1956, or

(ii) Eligible for registration as a medical practitioner under the relevant state laws pertaining to medical practitioner registration.

PROHIBITED ADVERTISEMENTS CATEGORIES

1. Advertisements of Drugs intended for the treatment of specific diseases and disorders, e.g.,

(a) For inducing miscarriage or preventing conception in women, or

(b) For correcting menstrual disorders in women, or

(c) For enhancing human sexual pleasure, or

(d) For diagnosing, curing, alleviating, treating, or preventing any diseases, disorders, or conditions as specified in the schedule or rules under this Act.

2. Advertisements of Magic Remedies claiming efficacy for any purposes specified in category 1 above for the treatment of specific diseases and disorders.

3. Misleading Advertisements related to drugs:
Advertisements concerning a drug or drugs that,

(a) Directly or indirectly present a false impression of the true nature of the drug or drugs, or

(b) Make false claims regarding such drug or drugs.

DISEASES, DISORDERS, AND CONDITIONS AS PER THE SCHEDULE

Appendicitis, Arteriosclerosis, Blindness, Blood poisoning, Bright's disease, Cancer, Cataract, Deafness, Diabetes, Diseases and disorders of the brain, optical system, and uterus, Disorders of menstrual flow, Nervous system, and prostatic gland, Dropsy, Epilepsy, Female diseases (in general), Fevers (in general), Fits, Form, and structure of the female bust, Gallstones, Kidney stones, and bladder stones, Gangrene, Glaucoma, Goitre, Heart diseases, High or low blood pressure, Hydrocele, Hysteria, Infantile paralysis, Insanity, Leprosy, Leucoderma, Lockjaw, Locomotor ataxia, Lupus, Nervous debility, Obesity, Paralysis, Plague, Pleurisy, Pneumonia, Rheumatism, Ruptures, Sexual impotence, Smallpox, Stature of a person, Sterility in women, Trachoma, Tuberculosis, Tumours, Typhoid fevers, Ulcers of the gastrointestinal tract, Venereal diseases including syphilis, Gonorrhoea, Soft chancre, Venereal granuloma, and Lymphogranuloma.

EXEMPTED ADVERTISEMENTS CATEGORIES

(Provision for Savings, under this Act):
The following advertisement types are not prohibited under this Act, meaning this Act does not apply to these types of advertisements.

1. Advertisements related to drugs printed or published by the Government or any other person with prior permission from the Government.

2. Advertisements regarding a drug sent confidentially in the prescribed manner to Registered Medical Practitioners.

3. Advertisements, including any book or treatise (a written or printed composition), addressing matters concerning diseases, disorders, or conditions that are otherwise prohibited, provided they are published from a genuine scientific or social perspective.

4. Displayed signboards or notices by Registered Medical Practitioners on their premises indicating that they provide treatment for diseases, disorders, or conditions specified in the schedule under this Act or in the rules made under this Act.

5. Advertisements related to drugs that comply with the following conditions:

(a) Leaflets or literature accompanying drug packaging, or advertisements of drugs in medicinal, pharmaceutical, scientific, and technical journals.

(b) Therapeutic index or price lists published by licensed manufacturers, importers, or distributors of drugs (under the Drugs and Cosmetics Act, 1940, and the rules thereunder), or medical literature distributed by Medical representatives.

With the condition that:

(i) The advertisement should only contain information necessary for registered medical practitioners regarding:

(a) Therapeutic indications;

(b) Route of administration;

(c) Dosage and side effects of such drug or drugs; and

(d) Precautions to be taken during treatment with the drug.

(ii) The distribution of such literature should be directed to registered medical practitioners, dispensaries, hospitals, medical and research institutions, chemists and druggists or pharmacies.

The Medical Termination of Pregnancy Act 1971 Rules 1975

The Medical Termination of Pregnancy Act 1971 Rules 1975

 

The Medical Termination of Pregnancy Act, 1971 Rules 1975 were enacted with the primary objective of facilitating the termination of specific pregnancies under the guidance of registered medical professionals.

 OBJECTIVE

 The primary aim of enacting this legislation was to authorize registered medical practitioners to carry out certain pregnancy terminations and address associated matters. 

DEFINITIONS

 - Guardian:

An individual responsible for the care of a minor or a mentally incapacitated person.

 - Minor:

A person, as defined by the Indian Majority Act of 1875, who has not yet reached the age of majority.

 - Registered Medical Practitioner:

A medical professional possessing a recognized medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956. Additionally, their name must be listed in a State Medical Register, and they must have relevant experience or training in gynecology and obstetrics, as stipulated by rules established under this Act.

 - Owner:

In the context of a location, "owner" refers to any person who holds administrative authority or responsibility for the operations or maintenance of a hospital or clinic.

 - Place:

This term encompasses any structure, tent, vehicle, vessel, or its part that serves as a facility for establishing or maintaining a hospital or clinic dedicated to pregnancy termination.

 

CIRCUMSTANCES UNDER WHICH PREGNANCIES MAY BE TERMINATED BY REGISTERED MEDICAL PRACTITIONERS

1. A registered medical practitioner may terminate a pregnancy if it is not more than 12 weeks old and the medical practitioner, in good faith, believes that:

       (a) Continuing the pregnancy would result in severe physical or mental harm to the pregnant woman, or

       (b) The child to be born would suffer severe physical or mental abnormalities.

2. If a pregnancy is more than 12 weeks but not exceeding 20 weeks, termination may occur with the concurrence of at least two registered medical practitioners when:

- The pregnancy resulted from rape or due to the failure of contraceptive devices used by a married woman or her spouse for family planning. In such cases, it is presumed to cause grave harm to the mental health of the pregnant woman. Evaluation may consider the pregnant woman's actual or reasonably foreseeable environment.

3. A registered medical practitioner may terminate a pregnancy for a woman aged 18 or older with her written consent.

4. For women under 18 or those over 18 but mentally incapacitated, written consent from their guardian is required. 

EXPERIENCE AND TRAINING

 The Medical Termination of Pregnancy Rules of 1975 stipulate the requisite experience and training in gynecology and obstetrics for registered medical practitioners to perform pregnancy terminations:

 - Medical practitioners registered in a State Medical Register before the enactment of this Act must possess a minimum of three years of experience in gynecology and obstetrics.

 - Medical practitioners registered in a State Medical Register after this Act's commencement can terminate pregnancies if they meet one of the following criteria:

    (i) Completion of six months of house surgency in gynecology and obstetrics.

    (ii) Minimum one-year experience in obstetrics and gynecology at any hospital.

  (iii) Participation in the performance of twenty-five cases of medical termination of pregnancy in a government-approved hospital, clinic, or training institute.

- Registered medical practitioners holding a post-graduate degree or diploma in gynecology and obstetrics are exempted from specific experience or training requirements. 

APPROVAL OF PREGNANCY TERMINATION FACILITIES

 Facilities for pregnancy termination can receive approval only when:

 (i) The government ensures that terminations occur under safe and hygienic conditions.

 (ii) The facility provides the necessary equipment and resources, including surgical instruments, anesthesia equipment, resuscitation tools, sterilization equipment, and emergency medications. 

MAINTENANCE OF ADMISSION REGISTER

 The Medical Termination of Pregnancy Regulations of 1975 mandate the maintenance of an Admission Register. The head of the hospital or the owner of an approved facility must maintain this register, following prescribed forms, to record the admission of women seeking pregnancy termination.

 Each entry in the Admission Register receives a unique serial number, with a new serial number assigned for each calendar year. It is essential to distinguish the serial numbers of different years (e.g., 7/1987 and 7/1988). The Admission Register is confidential, and the personal details of pregnant women must not be disclosed. 

OFFENCES AND PENALTIES

1. Performing a pregnancy termination by an unregistered medical practitioner is an offense punishable under the Indian Penal Code.

2. Any person who deliberately violates or fails to comply with state government regulations may face fines of up to one thousand rupees.

 

3. Registered Medical Practitioners are protected from legal action for any harm caused or likely to be caused in good faith under this Act.

 

Scrutiny of Applications for Registration

Scrutiny of application: 

Scrutiny of application for registration of Pharmacist in state register is done as follows-Applications for registration, accompanied by the prescribed fee, should be submitted to the Registrar of the State Pharmacy Council after the designated date. If the Registrar determines that the applicant possesses the necessary qualifications for registration, they may direct the inclusion of the applicant's name in the register. Individuals whose names have been removed from a state's register are not eligible to have their names reinstated without the approval of the State Council, granted during a meeting. If the Registrar rejects an application for registration, the applicant has the right to appeal to the State Council within three months from the date of rejection. The decision of the State Council in this regard is final. Upon the inclusion of a name in the register, the Registrar issues a certificate of registration in the prescribed form.

Renewal Fees:

To retain a name in the register after the 31st of December of the year following the year of initial registration, the prescribed fee must be paid annually before the 1st of April. If the renewal fee is not paid by the due date, the Registrar will remove the name of the defaulter from the register. However, the removed name may be reinstated in the register under the prescribed conditions after fulfilling the necessary requirements. Upon payment of the renewal fee, the Registrar issues a receipt, which serves as proof of registration renewal. Any additional qualifications obtained by a registered pharmacist shall be recorded in the register upon payment of the prescribed fee.

 Removal of Names from the Register:

The Executive Committee, after allowing the individual in question to explain their conduct and conducting a thorough inquiry, may order the removal of a registered pharmacist's name under the following conditions:

1. If the inclusion of the name in the register was due to an error or resulted from misrepresentation or the suppression of material facts.
2. If the registered pharmacist has been convicted of an offense or has engaged in infamous conduct in a professional capacity, making them unfit to remain in the register.
3. If a person employed by the registered pharmacist in connection with any pharmacy-related business has been convicted of an offense or engaged in infamous conduct and is also a registered pharmacist, their name may be removed from the register. Such an order is only made if the Executive Committee is satisfied that:

   (a) The offense or infamous conduct was instigated or planned by the registered pharmacist.

   (b) The registered pharmacist had committed a similar offense or was guilty of infamous conduct at any time during the twelve months preceding the date of the offense or infamous conduct.

   (c) Any person employed by the registered pharmacist in connection with any pharmacy-related business was guilty of a similar offense during the preceding twelve months, and the registered pharmacist was aware of this previous offense or infamous conduct.

   (d) The offense or infamous conduct persisted over an extended period, and the registered pharmacist had, or reasonably should have had, knowledge of its continuation.

   (e) The offense is a violation of the Drugs and Cosmetics Act, and the registered pharmacist failed to ensure compliance with the provisions of this Act at their place of business by individuals under their control.

 The removal of names from the register may be either permanent or for a specified period of time. The Executive Committee's order to remove a name from the register must be confirmed by the State Pharmacy Council and takes effect three months after the date of such confirmation. This period is likely provided to allow the person to seek alternative means of livelihood. An individual aggrieved by the order to remove their name may appeal to the State Government within thirty days from the date of receiving the order, and the decision of the State Government is final. A person whose name has been removed from the register is required to surrender their certificate of registration to the Registrar of the relevant Pharmacy Council, and the removed name shall be published in the Official Gazette.

 Restoration of Names to the Register:

The State Council may, at any time and for sufficient reasons, order the restoration of the name of a person removed from the register upon payment of the prescribed fee. If an appeal against the removal was made and rejected by the State Government, the name cannot be restored unless confirmed by the State Government.

 Issuance of Duplicate Certificates of Registration:

If it is demonstrated to the satisfaction of the Registrar that a certificate of registration has been lost or destroyed, the Registrar may issue a duplicate certificate in the prescribed form upon payment of the prescribed fee.

 Offenses and Penalties:

1. Falsely Claiming to be a Registered Pharmacist: Any person who falsely claims to be a Registered Pharmacist or uses any words or letters in connection with their name to suggest their entry in the register, when their name is not so registered, is punishable with a fine of up to five hundred rupees on the first conviction and with imprisonment of up to six months or a fine of up to one thousand rupees or both on any subsequent conviction. The use of descriptions such as Pharmacist, Chemist, Druggist, Pharmaceutist, Dispenser, Dispensing Chemist, or any combination of such words by a person indicates that their name is entered in a state's register. A person who is a registered pharmacist in another state and who, at the time of claiming registration in the state, has filed an application for registration, shall not be deemed guilty of the offense.
2. Dispensing by Unregistered Persons: Persons other than registered pharmacists, dispensing any medicine for patients, are liable for punishment with imprisonment of up to six months or a fine of up to one thousand rupees or both.
3. Failure to Surrender Certificate of Registration: This offense is also punishable with a fine of up to fifty rupees.

REGISTRATION OF PHARMACIST IN STATE REGISTER

The profession of pharmacy can be safeguarded by permitting only individuals with the necessary scientific and professional knowledge to enter it. Registering pharmacists not only maintains the quality of professionals entering the field but also bestows specific privileges upon those already practicing, making them aware of their duties and responsibilities.

 In India, the Pharmacy Act of 1948, in Chapter 4, mandates the registration of pharmacists in all states. The initial register of pharmacists must be established by the respective State Government as soon as this chapter takes effect. Afterward, a State Pharmacy Council is to be constituted, and the register is transferred to its custody for maintenance.

 The register contains the following information:

(a) Full name and residential address of the registered individual.

(b) Date of first entry into the register.

(c) Qualifications for registration.

(d) Professional address, and if employed, the employer's name.

(e) Any additional prescribed particulars.

 

Preparation of the Initial Register:

1. To prepare the initial register, the State Government must, through an official Gazette notification, form a Registration Tribunal comprising three members and appoint a Registrar as its secretary.

2. The State Government then specifies a deadline for submitting registration applications, accompanied by the prescribed fee.

3. The Registration Tribunal reviews all applications received by the specified date. If satisfied with an applicant's qualifications, it directs the inclusion of their name in the register. 

4. The first register is subsequently published as directed by the State Government. If anyone disagrees with the Registration Tribunal's decision as implied in the published register, they may appeal to the authority designated by the State Government within 60 days of publication.

5. The Registrar amends the register based on the authority's decision and issues a registration certificate in the prescribed format to each eligible person. 

6. After the State Council is constituted, the register is entrusted to its custody, and the government directs the application fee collected to be credited to the State Council.

 

Qualifications for Inclusion in the Initial Register:

 To have their name in the first register, an individual must:

1. Be at least 18 years old and reside or practice pharmacy in the State.
2. Hold a degree or diploma in pharmacy, pharmaceutical chemistry, or a chemist and druggist diploma from an Indian University, State Government, or a recognized foreign authority, or
3. Possess a degree from an Indian University other than pharmacy or pharmaceutical chemistry and have at least three years of experience in compounding drugs in a hospital or dispensary under medical practitioners' prescriptions, or
4. Pass an examination recognized by the State Government for compounders and dispensers, or
5. Have a minimum of five years' experience in compounding and dispensing in a hospital or dispensary under medical practitioners' prescriptions before the date notified by the Registration Tribunal for registration applications.

 

Subsequent Registers:

 After the State Government invites applications for registration in the first register and before the Education Regulations are enforced, individuals meeting the following criteria, and who are at least matriculate, can have their names in the register on payment of the prescribed fee:

1. Satisfy the conditions set for first register registration or, if no such conditions exist, meet the criteria for first register registration.
2. Are registered pharmacists in another State or
3. Hold qualifications for registration granted outside the territory governed by the Act.

 After the Education Regulations are enforced, individuals who are at least 18 years old, reside or practice pharmacy in the State, and meet the following criteria can have their names in the register on payment of the prescribed fee:

1. Pass an approved examination or
2. Possess qualifications granted outside the territory governed by the Act or are registered pharmacists in another State.

 

Special Provisions for Registration of Certain Persons (Sec. 32-A):

 The Pharmacy (Amendment) Act of 1959 introduced special provisions for the registration of specific classes of individuals, in addition to those eligible for subsequent register registration. These classes include:

1. Displaced persons practicing pharmacy before March 4, 1948, who meet the necessary first register conditions.
2. Indian citizens practicing pharmacy abroad who meet the necessary first register conditions.
3. Individuals residing in areas that were not part of India when the Pharmacy Act was passed but later became part of India, meeting the necessary first register conditions.
4. Individuals who applied for first register registration on or before the specified date but were not registered for various reasons.
5. Individuals with at least five years of experience in compounding drugs in a hospital or dispensary under medical practitioners' prescriptions before the date specified by the State Government.
6. Individuals qualified for registration in a State before November 1, 1956, who, due to territorial transfers, are not qualified for registration in the later State solely because they are not matriculates or do not possess qualifications recognized by the Pharmacy Council of India.
7. Individuals registered in a State before November 1, 1956, which later became part of another State and who practice pharmacy in the later State.
8. Individuals residing or practicing pharmacy in an area where the registration chapter applies after the commencement of the Pharmacy (Amendment) Act of 1959 and meet the first register's registration conditions.

 EDUCATION REGULATIONS

 In accordance with Section 10 of the Pharmacy Act 1948, the Central Council, subject to approval by the Central Government, has the authority to establish Education Regulations that define the minimum educational standards necessary for individuals aspiring to become qualified pharmacists. These regulations encompass:

 (a) The minimum prerequisites for admission into the program.

 (b) The curriculum's nature and duration.

 (c) The requisite practical training duration following the completion of the standard coursework, which includes a minimum of 75 hours over a period of three months at an institution, hospital, pharmacy, or dispensary recognized by the Central Council.

 (d) The subjects of examination and the expected level of proficiency in each.

 (e) The facilities and equipment institutions must provide to students pursuing an approved course of study.

 (f) The conditions that institutions offering practical training must meet.

 (g) The requirements governing authorities responsible for conducting approved examinations.

 Before submitting the Education Regulations or any proposed amendments to the Central Government for approval, the Central Council is obligated to distribute draft copies of the ER (Education Regulations) and any subsequent amendments to all State Governments. The Central Council also takes into account any comments received from State Governments within three months of sharing these documents. The Central Government subsequently publishes the ER in the Official Gazette as directed by the Central Council. The Executive Committee periodically evaluates the efficacy of the ER and may recommend amendments to the Central Council.

 

Application of Education Regulations to States:

Following the formation of the state council in accordance with Chapter 3 and subsequent consultation with the state council, the State Government can, through a notification in the Official Gazette, declare the application of ER within the state. If such a declaration is not made, ER becomes effective in the state three years after the establishment of the State Council.

 

PHARM.D. REGULATIONS 2008

 

The Pharm.D. (Doctor of Pharmacy) qualification serves as a prerequisite for registration as a pharmacist under the Pharmacy Act 1948. This qualification encompasses two program types:

 

1. Pharm.D.
2. Pharm.D. (Post Baccalaureate)

 

Duration of the Course:

- Pharm.D.: This program spans six academic years (five years of study and one year of internship or residency). Each academic year must consist of no less than 200 working days and is divided into two phases:

  - Phase I: Comprising the first, second, third, fourth, and fifth academic years.

  - Phase II: Involving internship or residency training during the sixth year in specialized hospital units, where students gain practical pharmacy experience.

 

- Pharm.D. (Post Baccalaureate): This program takes three academic years (two years of study and one year of internship or residency). Similar to Pharm.D., each academic year comprises a minimum of 200 working days and is divided into two phases:

  - Phase I: Covering the first and second academic years.

  - Phase II: Encompassing internship or residency training during the third year in specialized hospital units, exposing students to real-world pharmacy practice.

 

Minimum Qualification for Admission:

- For Pharm.D., eligibility requires either:

  (a) Successful completion of the 10+2 examination with Physics and Chemistry as compulsory subjects and either Mathematics or Biology.

  (b) A D.Pharm. qualification from a PCI-approved institution under section 12 of the Pharmacy Act.

  (c) Any other qualification approved by PCI as equivalent to the above exams. Applicants must also be at least 17 years old by December 31st of the year of admission.

 

- For Pharm.D. (Post Baccalaureate), admission necessitates a B.Pharm. qualification from a PCI-approved institution under section 12 of the Pharmacy Act.

 

Reservation:

Reserved seats are available for SC, ST, and OBC candidates, in accordance with directives issued by the Central Government, State Government, or Union Territory Administration, as applicable.

 

Number of Seats:

The number of seats for both Pharm.D. and Pharm.D. (Post Baccalaureate) is determined by PCI and may change over time. Presently, there are 30 seats for Pharm.D. and 10 for Pharm.D. (Post Baccalaureate). Institutions wishing to offer these programs must obtain prior approval from PCI.

 

Syllabus:

The curriculum for each subject in these programs is detailed in Appendix-A of these regulations.

 

Examination:

Examinations, encompassing theory, practical, and oral components, may occur twice annually—an annual and a supplementary examination. Theory exams are three hours long, while practical exams are four hours. Both theory and practical exams have a sessional component carrying 30 marks separately.

 

APPROVAL OF INSTITUTIONS OR AUTHORITIES PROVIDING COURSES OF STUDY AND EXAMINATIONS

 

1. Application by Institution/Authority to the Central Council:

Institutions or authorities responsible for conducting pharmacist education programs or examinations must apply to the Central Council for approval.

 

2. Inspection:

Upon receiving such applications, the Central Council dispatches inspectors to assess whether the institution meets the stipulated training and examination facilities outlined in the Education Regulations. These inspectors may also attend examinations to evaluate their standards without interfering with the exam's administration. The inspectors subsequently provide a report to the Council, outlining the adequacy of the institution's facilities and the standards of the conducted examinations.

 

3. Approval:

If the Central Council is satisfied, based on the inspectors' reports, that the institution's course or examination complies with ER, approval is granted. Such approved courses and examinations are deemed eligible for pharmacist registration under the Act.

4. Declaration:

The declaration of approval is made through resolutions passed at a Central Council meeting and is subsequently published in the official Gazette. All authorities conducting approved courses or examinations in the states must provide any information requested by the Central Council from time to time.