Commercialisation of healthcare in India: overview

A Q&A guide to the commercialisation of healthcare in India.

This Q&A provides an overview of the regulatory framework for the commercialisation of medical products in India. It covers the key requirements for manufacturing, advertising and selling drugs, medical devices, biological products and natural health products.

To compare answers across multiple jurisdictions, visit the commercialisation of healthcare Country Q&A tool.

This Q&A is part of the Commercialisation of Healthcare Global Guide. For a full list of jurisdictional Q&As visit www.practicallaw.com/healthcare-guide.

Contents

Regulatory overview

1. What is the regulatory framework for medical products?

Legislation

The regulatory framework for medical products includes the:

  • Drugs and Cosmetics Act 1940.

  • Drugs and Cosmetics Rules 1945.

  • Essential Commodities Act 1955.

  • Drug (Price Control) Order 2013.

  • Drugs and Magic Remedies (Objectionable Advertisements) Act 1954.

  • Drugs and Magic Remedies (Objectionable Advertisements) Rules 1955.

  • Food Safety and Standards Act 2006.

  • Pharmacy Act 1948.

  • Pharmacy Practice Regulations 2015.

Regulatory authorities

The main regulatory authorities are the:

  • Drugs Controller General of India (DCGI).

  • Central Drugs Standard Control Organisation (CDSCO).

  • State drug licensing authorities.

  • National Pharmaceutical Pricing Authority (NPPA).

  • Department of Pharmaceuticals (DOP).

  • Food Safety and Standards Authority of India (FSSAI).

  • Review Committee on Genetic Manipulation (RCGM).

  • Genetic Engineering Appraisal Committee (GEAC).

The authorities above are part of the following ministries:

  • Ministry of Health and Family Welfare: DCGI, CDSCO and FSSAI.

  • Ministry of Chemicals and Fertilisers: NPPA and DOP.

  • Ministry of Science and Technology: RCGM.

  • Ministry of Environment and Forests: GEAC.

  • State-level ministries such as the public health department (for state drug licensing authorities).

For more information on the relevant regulatory authorities see box: The regulatory authorities.

Private parties

The main industry organisations are the:

  • Organisation of Pharmaceutical Producers of India (OPPI).

  • Pharmaceutical & Allied Manufactures' & Distributors' Association Limited (PAMDAL).

  • Pharmaceuticals Export Promotion Council of India (PHARMEXCIL).

  • Indian Pharmaceutical Alliance (IPA).

  • Indian Drug Manufacturers' Association (IDMA).

  • Bulk Drug Manufacturers' Association (BDMA).

  • Association of Biotechnology Led Enterprises (ABLE).

  • Association of Medical Device Industry (AIMED).

  • Federation of Indian Chambers of Commerce and Industry (FICCI).

  • Confederation of Indian Industries (CII).

  • Associated Chambers of Commerce (ASSOCHAM).

  • PHD Chamber of Commerce and Industry.

  • American Chamber of Commerce in India (AMCHAM).

  • Indian Society for Clinical Research.

  • Basic Chemicals, Pharmaceuticals and Cosmetics Export Promotion Council (CHEMEXCIL).

The industry organisations are engaged in policy advocacy and self-regulation of their members.

 
2. What types of medical products are regulated?

In India, there are three categories of medical products for regulation purposes:

  • Drugs, including certain notified medical devices that are considered as drugs.

  • Medical devices that are not drugs.

  • Food.

The Drugs and Cosmetics Act 1940 is the single legislation that regulates all medical products other than food. Food is regulated by the Food Safety and Standards Act 2006. The applicable act depends on whether a product falls within the definition of "drug" under the Drugs and Cosmetics Act 1940. This definition is very broad and any medical product that makes a medicinal claim is regulated as a drug in India. Therefore, a food product with any medicinal claim is deemed to be a drug.

There are 14 categories of medical devices that have been notified by the Ministry of Health and Family Welfare as "drugs" (notified medical devices) and are regulated under the Drugs and Cosmetics Act 1940. Devices other than notified medical devices are not regulated in India. Medical products other than drugs are regulated as food under the Food Safety and Standards Act 2006.

 

Drugs

3. What are the general requirements for a drug to be manufactured, advertised and sold?

Manufacturing

The basic minimum requirement is that a manufacturer must have a drug manufacturing licence from the drug licensing authority of the state where the manufacturing premises are located. A licence must be obtained for each plant. Depending on the nature of the drug, an additional permission called "licence approval" may be required from the Drugs Controller General of India (DCGI).

For new drugs that are manufactured for use in clinical trials, a separate test manufacturing licence must be obtained from the drug licensing authority of the state where the manufacturing premises are located. This licence can only be issued after receipt of a no-objection certificate from the DCGI to manufacture the new drug.

After successful completion of a clinical trial, the DCGI grants a marketing permission to market the new drug in India. Without the marketing permission from the DCGI, the state drug licensing authority will not accept an application for a drug manufacturing licence (for general, non-clinical trial purposes) for a new drug.

A new drug is a drug whose safety and efficacy has not been established by clinical trials in India. A generic version of a proprietary drug which has been marketed in India for more than four years ceases to be a new drug. However, this does not apply to vaccines and drugs derived from recombinant DNA (r-DNA).

Advertising

All prescription drugs cannot be advertised in India unless a special sanction is obtained from the central government. Generally, prescription drugs are drugs that are listed under Schedule H, H1 and X of the Drugs and Cosmetics Rules 1945.

Non-prescription drugs can be advertised if they do not claim to cure, treat, prevent or mitigate certain diseases and conditions specified under Schedule J of the Drugs and Cosmetics Rules 1945.

There is a prohibition on advertising any drug in a manner that suggests, or is calculated to lead to the use of that drug for the:

  • Procurement of miscarriage.

  • Prevention of conception for women.

  • Correction of menstrual disorders.

  • Maintenance or improvement of sexual pleasure.

  • Diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Rules 1955.

Sale

All drugs must be sold under a wholesale or retail drug licence issued by the drug licensing authority of the state in which the wholesale or retail premises are located. Licences usually vary according to target purchasers (wholesale or retail sale) and the nature of the drug sold at the retail level.

 
4. Are there different requirements for patented and generic drugs?

The requirements for patented and generic drugs are the same, except for the requirement to conduct clinical trials to establish the safety and efficacy of new drugs. Manufacturers of patented drugs must conduct clinical trials in India to generate safety and efficacy data, whereas manufacturers of generic drugs can rely on the clinical trial data relating to the patented drug, and are not required to conduct new clinical trials.

 
5. What authority is responsible for regulating the manufacture, advertising and sale of drugs?

Manufacturing licences are issued by the state drug licensing authorities, but manufacturing activities are jointly regulated by the Drugs Controller General of India (DCGI) and state drug licensing authorities.

The advertising of prescription drugs is regulated jointly by the central government and the drug licensing authority of the state where the advertisement is made. The advertising of non-prescription drugs is regulated by the drug licensing authority of the state in which the advertisement is made. If an advertisement covers more than one state, the state drug licensing authorities of each state will have jurisdiction.

The sale of drugs is regulated by the drug licensing authority of the state in which the sale premises are located.

For more information on the DCGI and state drug licensing authorities see box: The regulatory authorities.

 
6. Are there fewer or different requirements for drugs that have already been licensed/approved in another jurisdiction?

There are no fewer or different requirements for the manufacturing, advertising or sale of drugs that have already been licensed/approved in other jurisdictions.

 
7. Is it possible to sell drugs to or buy drugs from other jurisdictions?

It is possible to sell drugs to or buy drugs from other jurisdictions.

An import licence from the Drugs Controller General of India (DCGI) is required to import drugs from other jurisdictions. An import licence can only be obtained after receipt of marketing approval from the DCGI for the drug (for new drugs only) and the grant of a registration certificate by the DCGI to the foreign manufacturer.

For new drugs that are imported for use in clinical trials, a separate test import licence must be obtained from the DCGI.

A new drug can be imported into India under a specific import licence granted to government hospitals and autonomous medical institutions in exceptional cases for the treatment of patients suffering from:

  • Life threatening diseases.

  • Diseases causing serious permanent disability.

  • Disease requiring therapies for unmet medical needs.

A specific import licence does not require marketing approval and foreign manufacturer registration. However, the new drug must be approved for marketing in the country of origin.

A new drug can also be imported into India by a patient for his personal use under a personal use permit on the basis of a prescription issued by a registered medical practitioner.

No special permission is required to sell domestically manufactured drugs in other jurisdictions. Manufacturers seeking to export drugs must have a manufacturing licence from the state drug licensing authority (and licence approval from the DCGI in certain cases).

 
8. Is it permitted to advertise drugs to consumers? Are there restrictions on advertising?

The advertising of drugs to consumers is heavily regulated. Prescription drugs cannot be advertised without the special sanction of the central government.

Advertisements to consumers cannot claim that a drug cures or prevents any diseases or ailments specified in Schedule J of the Drugs and Cosmetics Rules 1945. In addition, it is prohibited to advertise any drug in a manner that suggests, or is calculated to lead to the use of that drug for the:

  • Procurement of miscarriage.

  • Prevention of conception for women.

  • Correction of menstrual disorders.

  • Maintenance or improvement of sexual pleasure.

  • Diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Rules 1955.

 

Medical devices

9. What are the general requirements for a medical device to be manufactured, advertised and sold?

Manufacturing

There are 15 categories of medical devices that have been notified as "drugs" by the Ministry of Health (notified medical devices). Notified medical devices are regulated as drugs under the drug regulatory framework. Medical devices that do not fall within one of the 15 categories are not regulated in India.

Manufacturing notified medical devices requires a manufacturing licence from the state drug licensing authority and a licence approval from the Drugs Controller General of India (DCGI).

For new medical devices that are manufactured for use in clinical trials, a separate test manufacturing licence must be obtained from the drug licensing authority of the state where the manufacturing plant is located. This licence can only be issued after receipt of a no-objection certificate from the DCGI to manufacture the new device.

A new medical device is a notified medical device whose safety and efficacy has not been established by clinical trials in India.

Advertising

Advertisements for notified medical devices cannot claim to treat, prevent or mitigate certain diseases and conditions specified under Schedule J of the Drugs and Cosmetics Rules 1945. This restriction does not apply to medical devices that do not qualify as notified medical devices.

It is prohibited to advertise any medical device (whether notified or not) in a manner that suggests, or is calculated to lead to the use of that device for the:

  • Procurement of miscarriage.

  • Prevention of conception for women.

  • Correction of menstrual disorders.

  • Maintenance or improvement of sexual pleasure.

  • Diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Rules 1955.

While these restrictions were originally enacted to apply to drugs, their scope was extended by the courts to apply to medical devices.

Sale

All devices that fall into the category of notified medical devices must be sold under a wholesale or retail drug licence issued by the drug licensing authority of the state where the wholesale or retail premises are located. The sale of devices that do not fall within the category of notified medical devices do not require any licence or permission.

 
10. What authority is responsible for regulating the manufacture, advertising and sale of medical devices?

The manufacture of notified medical devices is regulated by the Drugs Controller General of India (DCGI) and the drug licensing authority of the state where the manufacturing premises are located.

The advertising of all medical devices is regulated by the drug licensing authority of the state where the advertisement is made. If an advertisement covers more than one state, the drug licensing authorities of each state will have jurisdiction.

The sale of notified medical devices is regulated by the drug licensing authority of the state where the sale premises are located.

There is no regulation on the manufacture and sale of medical devices that do not fall in the category of notified medical devices.

 
11. Are there fewer or different requirements for medical devices that have already been licensed/approved in another jurisdiction?

There are no fewer or different requirements for the manufacturing, advertising or sale of medical devices that have already been licensed/approved in other jurisdictions.

 
12. Is it possible to sell devices to or buy devices from other jurisdictions?

It is possible to sell medical devices to or buy medical devices from other jurisdictions.

Medical devices that do not qualify as notified medical devices can be imported or exported without any licence or permission.

Importing notified medical devices requires an import licence from the Drugs Controller General of India (DCGI). An import licence can only be issued on receipt of marketing approval from the DCGI for the medical device (for new medical devices only) and the grant of a registration certificate by the DCGI to the foreign manufacturer.

For new notified medical devices that are imported for use in clinical trials, a separate test import licence must be obtained from the DCGI.

A new medical device can be imported into India under a specific import licence granted to government hospitals and autonomous medical institutions in exceptional cases for the treatment of patients suffering from:

  • Life threatening diseases.

  • Diseases causing serious permanent disability.

  • Diseases requiring therapies for unmet medical needs.

A specific import licence does not require marketing approval and foreign manufacturer registration. However, the new medical device must be approved for marketing in the country of origin.

A new medical device can also be imported into India by a patient for his personal use under a personal use permit on the basis of a prescription issued by a registered medical practitioner.

No special permission is required to sell domestically manufactured medical devices in other jurisdictions. Manufacturers wishing to export notified medical devices must have a manufacturing licence from the relevant state drug licensing authority (and licence approval from the DCGI).

 
13. Is it permitted to advertise medical devices to consumers? Are there restrictions on advertising?

The advertising of medical devices to consumers is regulated. Advertisements for notified medical devices to consumers cannot claim that such devices can cure or prevent any diseases or ailments specified in Schedule J of the Drugs and Cosmetics Rules 1945.

In addition, it is prohibited to advertise any medical device (whether or not the device is a notified medical device) in a manner that suggests, or is calculated to lead to the use of that device for the:

  • Procurement of miscarriage.

  • Prevention of conception for women.

  • Correction of menstrual disorders.

  • Maintenance or improvement of sexual pleasure.

  • Diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act 1955.

 

Biological products

14. What are the general requirements for a biological product to be manufactured, advertised and sold?

Manufacturing

Manufacturing biological products requires a manufacturing licence from the relevant state drug licensing authority and a licence approval from the Drugs Controller General of India (DCGI).

For new biological products that are manufactured for use in clinical trials, a separate test manufacturing licence must be obtained from the state drug licensing authority of the state where the manufacturing premises are located. This licence can only be issued after receipt of a no-objection certificate from the DCGI to manufacture the new biological product.

The manufacture of biological products derived from recombinant DNA (r-DNA) technology may also require the approval of:

  • The Review Committee on Genetic Manipulation (RCGM), within the Department of Biotechnology.

  • The Genetic Engineering Appraisal Committee (GEAC), which is part of the Ministry of Environment and Forests.

A new biological product is a biological product whose safety and efficacy has not been established by clinical trials in India. Generic versions of vaccines and drugs derived from recombinant DNA (r-DNA) must be subject to clinical trials regardless of the duration for which the parent proprietary biological product has been marketed in India. For clinical trials and marketing approval of generic versions of biological products, the government introduced in 2012 the Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorisation in India.

Advertising

Biological products can be advertised if they are not claimed to treat, prevent or mitigate certain diseases and conditions specified under Schedule J of the Drugs and Cosmetics Rules 1945.

It is prohibited to advertise any drug, including biological products, in a manner that suggests, or is calculated to lead to the use of that product for the:

  • Procurement of miscarriage.

  • Prevention of conception for women.

  • Correction of menstrual disorders.

  • Maintenance or improvement of sexual pleasure.

  • Diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Rules 1955.

Sale

All biological products must be sold under a wholesale or retail drug licence issued by the drug licensing authority of the state in which the wholesale or retail premises are located. Licences usually vary depending on the target purchasers (wholesale or retail sale) and the nature of the biological product sold at the retail level.

 
15. What authority is responsible for regulating the manufacture, advertising and sale of biological products?

The manufacture of biological products is jointly regulated by the Drugs Controller General of India (DCGI) and the relevant state drug licensing authority. Depending on whether the biological product is derived from r-DNA technology, the approval of the Review Committee on Genetic Manipulation (RCGM) and Genetic Engineering Appraisal Committee (GEAC) may also be required prior to manufacturing.

The advertising of biological products is regulated by the drug licensing authority of the state where the advertisement is made. If the advertisement covers more than one state, the drug licensing authorities of each state will have jurisdiction.

The sale of biological products is regulated by the drug licensing authority of the state in which the sale premises are located.

For more information on the DCGI, RCGM, GEAC and state licensing authorities see box: The regulatory authorities.

 
16. Are there fewer or different requirements for biological products that have already been licensed/approved in another jurisdiction?

There are no fewer or different requirements for the manufacturing, advertising or sale of biological products that have already been licensed/approved in another jurisdiction.

 
17. Is it possible to sell biological products to or buy biological devices from other jurisdictions?

It is possible to sell biological products to or buy biological products from other jurisdictions.

An import licence from the Drugs Controller General of India (DCGI) is required to import biological products from other jurisdictions. An import licence can only be issued on receipt of a marketing approval from the DCGI for the biological products (for new biological products only) and the grant of a registration certificate by the DCGI to the foreign manufacturer.

For new biological products that are imported for use in clinical trials, a separate test import licence must be obtained from the DCGI.

A new biological product can be imported into India under a specific import licence granted to government hospitals and autonomous medical institutions in exceptional cases for the treatment of patients suffering from:

  • Life threatening diseases.

  • Diseases causing serious permanent disability.

  • Diseases requiring therapies for unmet medical needs.

A specific import licence does not require marketing approval and foreign manufacturer registration. However, the new biological product must be approved for marketing in the country of origin.

A new biological product can also be imported into India by a patient for his personal use under a personal use permit on the basis of a prescription issued by a registered medical practitioner.

No special permission is required to sell domestically manufactured biological products in other jurisdictions. Manufacturers wishing to export must have a manufacturing licence from the relevant state drug licensing authority and licence approval from the DCGI.

Human biological samples can be imported or exported for commercial purposes without prior approvals, provided that the Indian entity or its agent submits an undertaking that they comply with the applicable law relating to the safe transfer and disposal of biological samples.

 
18. Is it permitted to advertise biological products to consumers? Are there restrictions on advertising?

The advertising of biological products to consumers is regulated. Advertisements to consumers cannot claim that a biological product can cure or prevent any diseases or ailments specified in Schedule J of the Drugs and Cosmetics Rules 1945.

In addition, it is prohibited to advertise any biological product in a manner that suggests, or is calculated to lead to the use of that drug for the:

  • Procurement of miscarriage.

  • Prevention of conception for women.

  • Correction of menstrual disorders.

  • Maintenance or improvement of sexual pleasure.

  • Diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Rules Act 1955.

 

Natural health products

19. Is there a category for natural health products (including, for example, traditional medicines, homeopathic medicines, supplements, vitamins and minerals)?

There is no official category of natural health products under Indian law. Natural health products can be either:

  • Drugs. Products that make a medicinal claim are categorised as drugs and governed by the same regulatory framework as for drugs.

  • Food. Products that do not make a medicinal claim are categorised as food and governed by the regulatory framework that applies to food products.

Traditional medicines, homeopathic medicines, unani medicines and ayurvedic medicines are categorised as drugs under the Drugs and Cosmetics Act 1940. Foods for special dietary uses, functional foods, nutraceuticals and health supplements are categorised as food under the Food Safety and Standards Act 2006, provided that they do not make a medicinal claim.

 
20. What are the general requirements for natural health products to be manufactured, advertised and sold?

Manufacturing

Natural health products categorised as drugs. The basic minimum requirement is that a manufacturer must have a drug manufacturing licence from the drug licensing authority of the state in which the manufacturing premises are located and a licence approval from the Drugs Controller General of India (DCGI).

For new natural health products that are manufactured for use in clinical trials, a separate test manufacturing licence must be obtained from the drug licensing authority of the state in which the manufacturing premises are located. This licence can only be issued after receipt of a no-objection certificate from the DCGI to manufacture the new natural health product.

Natural health products categorised as food. The basic minimum requirement is that a manufacturer must have a drug manufacturing licence from the food licensing authority of the state in which the manufacturing premises are located. In certain cases, depending on the nature of the health product and the scale of operations, the manufacturing licence may be issued by the Food Safety and Standards Authority of India (FSSAI).

Advertising

Natural health products categorised as drugs. Over-the-counter natural health products can be advertised if they do not claim to treat, prevent or mitigate certain diseases and conditions specified under Schedule J of the Drugs and Cosmetics Rules 1945.

There is a prohibition on advertising any natural health product in a manner that suggests, or is calculated to lead to, the use of that product for the:

  • Procurement of miscarriage.

  • Prevention of conception for women.

  • Correction of menstrual disorders.

  • Maintenance or improvement of sexual pleasure.

  • Diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Rules 1955.

Natural health products categorised as food. Advertisements for natural health products must not be misleading or deceiving. Such advertisements must not:

  • Falsely represent that the products are of a particular standard, quality, quantity or composition.

  • Make a false or misleading representation concerning the need for, or the usefulness of the product.

  • Give to the public any guarantee of efficacy which is not based on an adequate or scientific justification.

Sale

Natural health products categorised as drugs. These must be sold under a wholesale or retail drug licence issued by the drug licensing authority of the state in which the wholesale or retail premises are located. Licences usually vary depending on the target purchasers (wholesale or retail sale) and the nature of the product sold at the retail level.

It is possible to sell ayurvedic products that are manufactured in accordance with an ancient Indian method without a licence.

Natural health products categorised as food. The sale of all natural health products requires a food business operator licence from the food licensing authority of the state where the sale premises are located. If the food business operator is operating in more than two states, then the licence is issued by the FSSAI.

 
21. What authority is responsible for regulating the manufacture, advertising and sale of natural health products?

Natural health products categorised as drugs

The manufacture of these products is jointly regulated by the Drugs Controller General of India (DCGI) and the relevant state drug licensing authority.

The advertising of these products is regulated by the drug licensing authority of the state where the advertisement is made. If the advertisement covers more than one state, the drug licensing authorities of each state will have jurisdiction.

The sale of natural health products is regulated by the drug licensing authority of the state in which the sale premises are located.

Natural health products categorised as food

The manufacture of food products is jointly regulated by the Food Safety and Standards Authority of India (FSSAI) and the relevant state food licensing authority.

The advertising of food products is jointly regulated by the FSSAI and the food licensing authority of the state where the advertisement is made. If the advertisement covers more than one state, the food licensing authorities of each state will have jurisdiction.

The sale of natural health products is regulated by the food licensing authority of the state in which the sale premises are located, or by the FSSAI if the food business is operated in more than one state.

For more information on the DCGI, FSSAI, state drug and food licensing authorities see box: The regulatory authorities.

 
22. Are there fewer or different requirements for natural health products that have already been licensed/approved in another jurisdiction?

There are no fewer or different requirements for the manufacturing, advertising or sale of natural health products that have already been licensed/approved in another jurisdiction.

 
23. Is it possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically?

It is possible to sell natural health products to or buy natural health products from other jurisdictions and/or electronically.

For more details on the requirements that apply to products categorised as drugs see Question 7.

 
24. Is it permitted to advertise natural health products to consumers? Are there restrictions on advertising?

Natural health products categorised as drugs

Over-the-counter natural health products can be advertised if they do not claim to treat, prevent or mitigate certain diseases and conditions specified under Schedule J of the Drugs and Cosmetics Rules 1945.

It is prohibited to advertise any natural health product in a manner that suggests, or is calculated to lead to, the use of that product for the:

  • Procurement of miscarriage.

  • Prevention of conception for women.

  • Correction of menstrual disorders.

  • Maintenance or improvement of sexual pleasure.

  • Diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Schedule to the Drugs and Magic Remedies (Objectionable Advertisements) Rules 1955.

Natural health products categorised as food

Advertisements of natural health products are permitted subject to the following restrictions. The advertisement of a natural health product must not be misleading or deceiving, and must not in particular:

  • Falsely represent that the foods are of a particular standard, quality, quantity or composition.

  • Make a false or misleading representation concerning the need for, or the usefulness of the product.

  • Give to the public any guarantee of efficacy which is not based on an adequate or scientific justification.

 

Reform

25. Are there any plans to reform the rules on the development, manufacture, advertising and sale of medical products?

The overhaul of the regulatory framework for medical devices and biological products (especially biosimilars) is expected in the near future through amendments to the Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945. Notable proposals include:

  • Dedicated regulation of medical devices (currently, only notified medical devices are regulated as drugs). The Ministry of Health and Family Welfare has published a draft of the proposed Medical Device Rules 2016.

  • The inclusion of biological products such as stem cells within the regulatory framework.

  • A comprehensive regulation of clinical trials.

  • New guidelines for the grant of marketing approval of similar biologics (biosimilars). A draft of new guidelines has been published in 2016.

In addition, in light of the central government's "Make in India" campaign, certain policy changes regarding financial support, tax incentives and ease of doing business are expected to be set out for multinational companies that set up a manufacturing base in India.

The central government is also considering a proposal to establish price controls over all medical products.

 

The regulatory authorities

Drugs Controller General of India (DCGI)

W www.cdsco.nic.in

Principal responsibilities. The DCGI grants various permissions, licences and licence approvals for the import, manufacture, marketing and conduct of clinical trials of new medical products (other than natural health products that are categorised as food).

State drug licensing authorities

W Various websites. Two important state drug licensing authorities are the:

Principal responsibilities. These authorities are responsible for granting various licences for the manufacture and sale of medical products, and regulate advertisements of medical products.

National Pharmaceutical Pricing Authority

W www.nppaindia.nic.in

Principal responsibilities. The National Pharmaceutical Pricing Authority regulates the prices of essential medical products listed in the National List of Essential Medicines 2011.

Food Safety and Standards Authority of India (FSSAI)

W www.fssai.gov.in

Principal responsibilities. The FSSAI sets out science-based standards for articles of food (that is, natural health products that do not make medicinal claims) and regulates their manufacture, storage, distribution, sale and import by issuing product approvals, registrations and licences.

State food licensing authorities

W Various websites. Two important state drug licensing authorities are the:

Principal responsibilities. These authorities are responsible for granting various licences for the manufacture and sale of food (that is, natural health products that do not make medicinal claims), and regulating advertisements of food products.

Review Committee on Genetic Manipulation (RCGM)

W The RCGM does not have a dedicated website. Updates about the RCGM are available at http://dbtbiosafety.nic.in/.

Principal responsibilities. The RCGM is responsible for authorising the import/export of r-DNA products for research and development, and for the review of data up to pre-clinical evaluation.

Genetic Engineering Appraisal Committee (GEAC)

W The GEAC does not have a dedicated website. Updates about the GEAC are available at http://envfor.nic.in/.

Principal responsibilities. The GEAC is the statutory body that reviews and approves activities and products involving the large-scale use of genetically engineered organisms (also referred to as living modified organisms) in research and development, industrial production, environmental release and field applications.



Online resources

Drugs Controller General of India (DCGI)

W www.cdsco.nic.in

Description. Official website of the DCGI. All guidelines, notices, circulars, orders and amendments relating to medical products are uploaded on this website.

Food Safety and Standards Authority of India (FSSAI)

W www.fssai.gov.in

Description. Official website of the FSSAI. All guidelines, notices, circulars, orders and amendments relating to natural health products that do not make medicinal claims are uploaded on this website.



Contributor profiles

Milind Antani, Partner

Nishith Desai Associates

T +91 22 6669 5000
F +91 22 6669 5001
E milind.antani@nishithdesai.com
W www.nishithdesai.com

Professional qualifications. India, Lawyer

Areas of practice. Pharma and healthcare; social sector.

Non-professional qualifications. LLB, India, 2004; India, ENT Surgeon, MS, 1989

Languages. English, Hindi, Gujarati

Publications

  • Indian Pharma and Life Science Industry - Legal and Tax Framework, CCH, Walter Kluwers publishing.

  • Contract Research and Manufacturing Services (CRAMS) in India: The Business, Legal, Regulatory and Tax Environment in the Pharmaceutical and Biotechnology (Woodhead Publishing Series in Biomedicine).

Anay Shukla, Associate

Nishith Desai Associates

T +91 22 6669 5141
F +91 22 6669 5003
E anay.shukla@nishithdesai.com
W www.nishithdesai.com

Professional qualifications. BA LLB (Hons)

Areas of practice. Regulatory; domestic commercial law; international commercial law; dispute resolution; privacy law; criminal law; intellectual property law.

Languages. English

Darren Punnen, Associate

Nishith Desai Associates

T +91 22 6669 5141
F +91 22 6669 5003
E darren.punnen@nishithdesai.com
W www.nishithdesai.com

Professional qualifications. BA LLB (Hons)

Areas of practice. Regulatory; domestic commercial law; international commercial law; dispute resolution; privacy law; intellectual property law.

Languages. English


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