Medicinal product regulation and product liability in India: overview

A Q&A guide to medicinal product regulation and product liability law in India.

The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in India: overview.

To compare answers across multiple jurisdictions, visit the Life Sciences Country Q&A tool.

The Q&A is part of the global guide to life sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Contents

Regulatory overview

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

Legislation

The regulatory framework of authorisation, pricing and reimbursement of drugs is governed by the Drugs and Cosmetics Act 1940(as amended up to 2008) and the Drugs and Cosmetics Rules 1945 (as amended up to 2003).

Regulatory authorities

The regulatory authorities for drug authorisation are as follows:

  • Drugs Controller General of India (DCGI).

  • Central Drugs Standard Control Organization (CDSCO).

  • Institutional/Independent Ethics Committee.

  • State Controlling Authority.

  • State Licensing Authority.

  • Indian Council of Medical Research.

  • Drug Technical Advisory Board.

The DCGI (www.cdsco.nic.in), working under the auspices of the CDSCO, is the key regulator for regulating the authorisation process of medicinal products. The DCGI's office is responsible for granting regulatory approval for the manufacture, marketing and import of drugs in India, as well as ensuring compliance with drug safety and quality standards.

 
2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.

Similar biologics are regulated as per:

  • Drugs and Cosmetics Act 1940.

  • Drugs and Cosmetics Rules 1945.

  • Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989 notified under the Environment (Protection) Act 1986.

    The relevant applicable guidelines are the:

  • Recombinant DNA Safety Guidelines 1990.

  • Guidelines for generating pre-clinical and clinical data for rDNA vaccines, diagnostics and other biologicals 1999.

  • Central Drugs Standard Control Organization (CDSCO) guidance for industry 2008, which provides general considerations for conducting clinical trials, including:

    • Submission of Clinical Trial Application for Evaluating Safety and Efficacy;

    • Requirements for permission of New Drugs Approval;

    • Post approval changes in biological products: Quality, Safety and Efficacy Documents;

    • Preparation of the Quality Information for Drug Submission for New Drug Approval: Biotechnological/Biological Products.

  • Guidelines and Handbook for Institutional Biosafety Committees (IBSCs) 2011.

In 2012, Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorisation in India were released by the Department of Biotechnology, Ministry of Science and Technology, and the CDSCO.

The regulatory authorities involved in the regulation of biologics are as follows:

  • Recombinant DNA Advisory Committee.

  • Institutional Biosafety Committee.

  • Review Committee on Genetic Manipulation.

  • Genetic Engineering Approval Committee.

  • State Biotechnology Co-ordination Committee.

  • District Level Committee.

  • Drugs Controller General of India.

For further information, see the official website of the Department of Biotechnology, operating under the Ministry of Science and Technology (http://dbtindia.nic.in).

 
3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?

The Drugs and Cosmetics Act 1940 (Drugs and Cosmetics Act) (section 3(b)( iv)) and Drugs and Cosmetics Rules 1945 (Drugs and Cosmetic Rules) currently only regulate notified medical devices, that have been notified as drugs by the Indian government. Examples of notified devices are:

  • Drug eluting stents.

  • Disposable hypodermic syringes.

  • Orthopaedic implants.

For further information, see www.cdsco.nic.in/writereaddata/FAQ-IMPORT%20&%20REGISTRATION%2002022013_DONEE.pdf .

On 29 August 2013, the government introduced the Drugs and Cosmetics (Amendment) Bill 2013. This includes a chapter on the import, manufacture, sale, distribution and export of medical devices and on regulating the conduct of clinical trials in India. Further amendments to this Bill have been proposed, though they have not yet been introduced before Parliament.

In vitro diagnostic kits/reagents (IVD kits/reagents) are regulated in India under the Drugs and Cosmetic Act and Drugs and Cosmetic Rules. Diagnostic kits and reagents are classified as notified and non-notified. To import notified IVD kits/reagents into India, a registration certificate in Form 41 and an import licence in Form 10 are required, as per the Drugs and Cosmetic Act and Drugs and Cosmetic Rules. To import notified IVD kits/reagents, the manufacturing site and products (IVD kits/reagents) must be registered with the Central Drugs Standard Control Organization.

For further information, see http://cdsco.nic.in/writereaddata/Final%20FAQS-IVD.pdf .

 

Pricing, state funding and reimbursement

4. What is the structure of the national healthcare system, and how is it funded?

At the governmental level, the national healthcare system is regulated at two different levels, that is, the central level and the regional level. While the Ministry of Health and Family Welfare (http://mohfw.nic.in) is the policy maker and regulator at the central level, the State Department of Health and Family Welfare performs the same role for their respective region. The Department of Pharmaceuticals was set up in 2008 to promote growth and development of infrastructure in the drugs and pharmaceutical sector. In November 2014, the Government of India formed the Ministry of Ayush for the purposes of furthering research and developing Indian traditional medicine (Ayurveda), yoga, naturopathy, homeopathy, unani and other alternative forms of medicine.

Healthcare is one of India's largest sectors both in terms of revenue and employment, with the sector accounting for about 5% to 6% of India's GDP. The healthcare sector in India is projected to grow at a rate of US$40 billion per year. The private sector accounts for nearly 80% of the spending on healthcare in India.

 
5. How are the prices of medicinal products regulated?

The government issued a Drugs Price Control Order in 1995 under which the government has the power to set maximum sales prices of bulk drugs (bulk drugs are pharmaceutical, chemical, biological or plant products including their esters, salts, isomers and other derivatives conforming to the pharmacopeia or standards set by the Drugs and Cosmetics Act). This price setting is done to ensure equitable distribution of such bulk drugs.

The government established the National Pharmaceutical Pricing Authority (NPPA) (www.nppaindia.nic.in/index1.html), which has the following objectives:

  • Fixing and revising prices of bulk drugs and formulations.

  • Enforcing provisions of the Drugs Price Control Order and monitoring the prices of bulk drugs and formulations containing a bulk drug individually or in combination with other drugs.

On 7 December 2012 the government issued the National Pharmaceuticals Pricing Policy 2012. This has the limited objective to promulgate the principles for pricing of "Essential Drugs", as laid down in the National List of Essential Medicines 2011.

In May, 2013, the Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers notified the Drug (Prices Control) Order 2013. This permits the NPPA to regulate the prices of 348 essential drugs.

 
6. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?

India does not have a specific programme under which medicinal products are funded by the state or reimbursed to the patient. However, specific schemes exist to reduce the healthcare costs of patients who are below the poverty line. For instance, private hospitals have been provided incentives (for example land at subsidised rates) for providing free treatment and medicinal products to patients below the poverty line.

In particular, the National Health Mission under the aegis of the Ministry of Health and Family Welfare, provides funding to government hospitals in order to provide free medical care and certain medicinal products for free, or for subsidised rates. Each State Department of the Ministry of Health and Family Welfare identifies and provides certain drugs and medical procedures as Essential Drugs, and provides them for free or at nominal charges, at the government-owned or government-managed hospitals.

Further, private hospitals have also been given certain incentives (for example land at subsidised rates) for providing free treatment and medicinal products to patients below the poverty line.

Apart from the above, some state governments have made provisions for allocation of funds for treatment of rare diseases. For instance, the State Government of Karnataka in its annual budget for the year 2014 to 2015 had identified that patients suffering from certain rare diseases such as Lysosomal Storage Disorders were to be given due treatment at specified medical institutions.

 

Clinical trials

7. Outline the regulation of clinical trials.

Legislation and regulatory authorities

The Drugs and Cosmetics Act 1940 (Drugs and Cosmetics Act) is the principal legislation that governs clinical trials in India. More specifically, Schedule Y to the Drugs and Cosmetics Act was inserted in 2005, which sets out the requirements and guidelines for the import and manufacture of new drugs in India.

The Indian Council for Medical Research (ICMR) passed the Ethical Guidelines for Biomedical Research on Human Participants, which include:

  • Ethical review procedures.

  • General ethical issues.

  • Clinical evaluation.

  • Epidemiological studies.

  • Human genetics and genomics research.

  • Transplantation research.

  • Assisted reproductive technologies.

In 2002 the Department of Biotechnology passed the Ethical Policies on the Human Genome, Genetic Research and Services, which provides for the regulation and control of genetic studies and genome level research.

Authorisations

Under Schedule Y of the Drugs and Cosmetics Act, approval for clinical trials must be obtained from a Licensing Authority and from the respective ethics committee(s).

The Licensing Authority must be informed of the approval of the respective institutional ethics committee(s) and the trial initiated at each respective site only after obtaining such an approval for that site.

The clinical trial sponsor is responsible for implementing and maintaining quality assurance systems to ensure that the clinical trial is conducted and the data generated is documented and reported in compliance with the protocol and Good Clinical Practice (GCP) Guidelines, as well as with all applicable statutory provisions.

The investigator(s) are responsible for the conduct of the trial according to the protocol and the GCP Guidelines.

Consent

In all trials, a freely given, informed written consent must be obtained from each study subject.

The investigator must provide information about the study verbally as well as through a patient information sheet, in a language that is non-technical and understandable by the study subject.

The subject's consent must be obtained in writing using an Informed Consent Form (ICF). Both the patient information sheet and the ICF must be approved by the ethics committee and given to the Licensing Authority.

Any changes in the informed consent documents must be approved by the ethics committee and submitted to the Licensing Authority before such changes are implemented.

Taking a strict view of regulatory gaps and an increasing incidence of mismanagement and abuse, in October 2013 the Supreme Court stayed about 157 clinical trial programmes pending scrutiny by expert committees set up earlier. The Supreme Court has further mandated that no trials for new drugs will be allowed until the consent of the subject is recorded through an audio-visual medium.

The draft guidelines formulated by the Central Drugs Standard Control Organization (CDSCO) in this regard are available at:www.cdsco.nic.in/writereaddata/Guidance_for_AV%20Recording_09.January.14.pdf

Trial pre-conditions

The Drugs Controller General of India made trial registration in the Clinical Trials Registry India (CTRI) mandatory with effect from 15 June 2009.

The "Responsible Registrant" for a trial is either the principal investigator or the primary sponsor, to be decided by an agreement between the parties. The primary sponsor is ultimately accountable for ensuring that the trial is properly registered.

Procedural requirements

The procedural requirements and practices to be adopted while conducting clinical trials are detailed in the Good Clinical Practices Guidelines published by the CDSCO. These guidelines evolved taking into consideration the World Health Organization, International Conference on Harmonisation, US Food and Drug Administration and European Good Clinical Practice guidelines, as well as the Ethical Guidelines for Biomedical Research on Human Participants issued by the Indian Council of Medical Research (ICMR). These guidelines provide for:

  • Procedures for informed consent process.

  • Procedures for compensation and confidentiality.

  • Special requirements for clinical trials relating to vaccines, contraceptives, surgical devices.

The guidelines must be followed when carrying out all biomedical research in India at all stages of drug development, whether before or subsequent to product registration in India.

The ICMR prescribed Ethical Guidelines for Biomedical Research on Human Participants ought to be adhered to while conducting clinical trials. These guidelines focus on the ethical aspects of issues such as, informed consent and compensation for participation.

 

Manufacturing

8. What is the authorisation process for manufacturing medicinal products?

Application

The application for a drug manufacturing licence is made to the relevant State Licensing Authority (Licensing Authority), which scrutinises the application and sends it to any of the following three authorities:

  • Drugs Controller General of India (DCGI).

  • Joint Drugs Controller of India.

  • Deputy Drugs Controller of India.

Conditions

The following criteria are assessed by the Licensing Authority while granting authorisation for manufacturing medicinal products:

  • The qualifications and experience of the expert staff responsible for the manufacture, testing of the drugs and the operations at the manufacturing site.

  • The provision of adequate space, plant and equipment for manufacturing operations.

  • The provision of adequate arrangements for storage of manufactured drugs.

  • For homeopathic drugs, the applicant must ensure that homeopathic drugs are not manufactured simultaneously with drugs pertaining to other systems of medicinal products.

Restrictions on foreign applicants

Foreign applicants must establish a separate legal entity in India for undertaking manufacturing activities. Such Indian entities are subject to Indian law regulating the manufacture of drugs. The most common legal entity structure used is a subsidiary to the foreign applicant.

Key stages and timing

The key stages for obtaining authorisation for manufacturing of medicinal products are:

  • Application for authorisation for manufacturing of medicinal products.

  • Inspection by an inspector appointed by the government assessing compliance with the conditions for obtaining authorisation.

  • The inspector submits a report to the concerned authority.

  • The statutory authority, that is, DCGI, Joint Drugs Controller of India or the Deputy Drugs Controller of India, assesses the application.

Period of authorisation and renewals

The manufacturing authorisation is valid for a term of five years from the date of issue. For new drugs, it is valid for three years. An application for renewal can be made to the DCGI either during the term of the licence or within six months of its expiry.

Monitoring compliance and imposing penalties

The Licensing Authority has the power to appoint inspectors to make periodic visits to the manufacturing facility to ensure compliance with the conditions on which the manufacturing authorisation was granted.

In cases of non-compliance with the conditions on which the manufacturing authorisation was granted, the DCGI can either suspend or cancel the licence or direct the licensee to cease manufacture or sale of medicinal products.

 

Marketing

Authorisation and abridged procedure

9. What is the authorisation process for marketing medicinal products?

Application

An application for the authorisation to market new drugs must be made to the Licensing Authority as prescribed under the Drugs and Cosmetics Act 1940 (Drugs and Cosmetics Act) and the Drugs and Cosmetics Rules 1945 (Drugs and Cosmetic Rules).

Authorisation conditions

The substantive legal requirements to obtain a marketing authorisation (MA) are largely the same irrespective of the procedure followed. In assessing whether to grant an MA, the Licensing Authority assesses the medicinal product's:

  • Quality.

  • Safety.

  • Efficacy.

  • Risk-benefit balance.

Applicants must also submit the relevant particulars and documents to the Licensing Authority (under Schedule Y of the Drugs and Cosmetics Rules). Applicants must submit a clinical dossier with the relevant information which includes, among other things, the:

  • Results of local clinical trials data.

  • Chemistry, manufacturing and controls (CMC).

  • Quality data.

The norms prescribed for obtaining MA have to be adhered to even post-market entry (see above, Authorisation conditions). If the authorised entity is found to be in contravention of the terms of approval, penal consequences under the Drugs and Cosmetics Act will be imposed.

Key stages and timing

Applicants must submit applications only after conducting clinical trials conforming with Schedule Y of the Drugs and Cosmetics Rules. When considering the application, the DCGI can either grant or reject the application.

There is no statutory time frame within which applications must be processed and time frames often vary from case to case.

Fee

The fees for obtaining MAs are listed on the relevant Licensing Authority's website (www.cdsco.nic.in).

Period of authorisation and renewals

The MA does not have a specific period and lasts indefinitely.

Monitoring compliance and imposing penalties

The Drugs and Cosmetics Act read with the Drugs and Cosmetics Rules, contains specific provisions for appointment of inspectors who can visit manufacturing sites in order to ensure compliance with the conditions or specifications for granting of the MA.

The Drugs and Cosmetics Act imposes criminal penalties on those manufacturing or selling drugs without MA or in breach of MAs. These penalties include either:

  • Imprisonment, which can be up to a period of three years.

  • Imposing a fine on the defaulting party.

 
10. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? Are there further conditions concerning how the drug is distributed and accessible to patients?

In July 2010, the Central Drugs Standard Control Organization (CDSCO) initiated the Pharmacovigilance Programme of India for ensuring drug safety. The goal of the programme is to ensure that the benefits of use of medicines outweigh the risks. The programme's objectives include the following:

  • Monitoring adverse drug reactions (ADRs) in the Indian population.

  • Creating awareness in healthcare professionals about the importance of ADR reporting in India.

  • Monitoring benefit-risk profiles of medicines.

  • Generating independent, evidence-based recommendations on the safety of medicines.

  • Supporting the CDSCO in formulating safety related regulatory decisions for medicines.

  • Communicating findings with all key stakeholders.

  • Creating a national centre of excellence, with the same proficiency as global drug safety monitoring standards.

 
11. Which medicinal products can benefit from the abridged procedure for marketing authorisation and what conditions and procedure apply? What information can the applicant rely on?

India has weak provisions for data exclusivity or data protection. Subsequent applicants often rely on the studies, including results of clinical trials, conducted by the new drug applicant by establishing bioequivalence with the reference product. This helps in establishing whether the authorisation is sought for a drug that has the same active substance as the reference product. In 2005, the Central Drugs Standard Control Organization published the Draft Guidelines for Bioavailability and Bioequivalence studies, which provide guidance as to the manner in which bioequivalence can be established by generic companies in order to obtain accelerated marketing authorisations.

Additionally the legislature may also contemplate stronger data exclusivity provisions introduced in the near future. At present a limited amendment has been proposed in the Pesticides Management Amendment bill 2008 to include a limited data exclusivity provision for the data submitted for registration of a new pesticide.

 
12. Are foreign marketing authorisations recognised in your jurisdiction?

If a pharmaceutical product has obtained marketing authorisation in countries outside India, phase III clinical trial data must be obtained on at least 100 patients distributed over three to four centres in India to confirm the efficacy and safety of the drug on Indian patients, before the product can be marketed in India.

 

Parallel imports

13. Are parallel imports of medicinal products into your jurisdiction allowed?

The law relating to the exhaustion of rights under the Trade Marks Act 1999 is currently pending adjudication by the Supreme Court (Samsung Electronics v Kapil Wadhwa & Ors). The Supreme Court is being called on to decide whether Indian trade mark law recognises the principle of international exhaustion.

The Patents Act 1970, under section 107A(1), states that the importation of goods which are subject to patent protection in India by any person, from a person who is duly authorised by law to produce or sell or distribute the patented product, is not an act of infringement. This implies that Indian patent law recognises the principle of international exhaustion, provided that the goods originate from a duly authorised person.

On 8 May 2012, the Central Board of Excise and Customs (Circular No. 13/2012-Customs) notified that the issue of parallel imports (that is, permitting imports of original/genuine products (not counterfeit or pirated) sold/acquired legally abroad and imported into India, by persons other than the intellectual property right holder without its permission/authorisation) had been referred to the Department of Industrial Policy and Promotion, Ministry of Commerce and Industries, to seek clarification. This Department, which is the nodal authority for all matters relating to the Trade Marks Act, the Patents Act and the Designs Act, among other things, determined that:

  • Section 107A(b) of the Patents Act provides that importation of patented products, by any person from a person who is duly authorised under law to produce and sell or distribute the product, is not considered an infringement of patent rights. Therefore, in relation to patents, section 107A(b) provides for parallel imports.

  • Section 30(3)(b) of the Trade Marks Act provides that where goods bearing a registered trade mark are lawfully acquired, further sale or other dealing in such goods by the buyer, or a person claiming to represent him, is not considered an infringement by reason only of the goods being put on the market under the registered trade mark by the proprietor or with his consent. However, such goods should not be materially altered or impaired after they are put on the market.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, see Pharmaceutical IP and Competition Law in India: overview ( www.practicallaw.com/3-566-3907) .

 

Restrictions on dealings with healthcare professionals

14. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?

The Organisation of Pharmaceutical Producers of India (OPPI) published the Code of Pharmaceutical Marketing Practices 2010, which mandates that:

  • No cash or monetary grants for an individual purpose in an individual capacity under any pretext are to be provided to healthcare professionals (HCPs).

  • Funding for medical research study, for example, can only be given through approved institutions by modalities laid down by law, rules or guidelines adopted by such approved institutions, in a transparent manner.

  • Gifts to HCPs (including, but not limited to, music CDs, DVDs, sporting or entertainment tickets and electronic items) must not be provided or offered.

The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002, as amended in 2009, provide that:

  • A physician must not give, solicit, or receive, or offer to give, solicit or receive, any gift, gratuity, commission or bonus in consideration of or in return for the referring, recommending or procuring of any patient for medical, surgical or other treatment.

  • A physician must not, directly or indirectly, participate in or be a party to an act of division, transference, assignment, subordination, rebating, splitting or refunding of any fee for medical, surgical or other treatment.

  • A medical practitioner must not receive any gift from any pharmaceutical or allied healthcare industry and their sales people or representatives.

 

Sales and marketing

15. What are the restrictions on selling medicinal products? Are there specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order?

There are no specific requirements for entities marketing medicinal products on the internet. However, they must comply with the advertising, packaging and labelling requirements as prescribed for medicinal or pharmaceutical products.

The rise of e-commerce marketplaces in India has raised certain issues regarding the lack of regulation of sale of medicines online. State drug regulators are currently investigating certain complaints against such e-commerce marketplaces for sale of prescription drugs on their portals.

Details relating to the applicable licences, forms and fees in respect of sale can be accessed at: www.drugscontrol.org/FormsFees.asp.

 

Advertising

16. What are the restrictions on advertising medicinal products?

Legislation and regulatory authority

Advertising of medicinal products is primarily governed by legislation and regulations, including the:

  • Drugs and Cosmetics Act 1940.

  • Drugs Control Act 1950.

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

In addition, there are several self-regulating codes of ethics such as:

  • Code of Ethics for advertising in India issued by the Advertising Standard Council of India.

  • Code of Standards in relation to the advertising of medicinal products and treatments.

  • Standards of practice for Advertising Agencies.

  • Advertising Standards Council of India.

  • Organisation of Pharmaceutical Producers of India Code of Pharmaceutical Marketing Practices 2010.

Restrictions

The Drugs and Magic Remedies Act:

  • Prohibits certain kinds of advertisements pertaining to drugs and medicinal products.

  • Has an exhaustive list of ailments for which no advertising is permitted such as:

    • diabetes;

    • cataract;

    • cancer;

    • obesity;

    • rheumatism;

    • glaucoma;

    • dropsy.

  • Prohibits false or misleading advertisements that, directly or indirectly:

    • give false impressions regarding the true character of the drug;

    • make false claims; or

    • are otherwise false or misleading in any respect.

  • Prohibits advertisements of magic remedies for treatment of certain diseases and disorders.

Unfair trade practices such as adopting any unfair methods (for example, misleading advertisements for the purpose of promoting sale) are covered under the Consumer Protection Act 1986 (Consumer Protection Act). The Consumer Forum (which is a statutory body responsible for adjudicating disputes under the Consumer Protection Act) can direct the issuance of corrective advertisement for neutralising the effect of misleading advertisements.

Internet advertising

There is no separate legislation or regulation that concerns internet advertising specifically. However, the provisions under various laws apply in relevant circumstances.

 

Data protection

17. Do data protection laws impact on pharmaceutical regulation in your jurisdiction?

Data protection is still in its early stages in India. The Satwant Reddy Committee was set up in 2004, to review the steps to be taken by the government in the context of Data Protection Provisions under Article 39.3 of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS). The Committee in its report of 31 May 2007 opined that while test data for pharmaceuticals should be protected as a trade secret under common law, it recommends a protection period of exclusive rights to the company's test data of three years for new agro chemicals, and of five years for companies registering new traditional medicine.

The Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011 defines sensitive personal data, or information of a person as such personal information, which consists of information relating to:

  • Passwords.

  • Financial information such as a bank account, credit card or debit card or other payment instrument details.

  • Physical, physiological and mental health condition.

  • Sexual orientation.

  • Medical records and history.

  • Biometric information.

  • Any detail relating to the above items provided to a body corporate for providing a service.

  • Any of the information received under the above items by a body corporate for processing, or stored or processed under a lawful contract or otherwise.

However, any information that is freely available or accessible in the public domain or provided under the Right to Information Act 2005 or any other law in force is not regarded as sensitive personal data or information for the purposes of these rules.

Combined provisions from the Information Technology Act 2000, the Contract Act 1872 and the Penal Code 1860 can be invoked to protect certain data, as well as enforce rights against data related offences. However, there is no specific instance that can be cited at this stage. There have been recommendations to the government emphasising the benefits of protecting data for a wide range of persons, from the patient to the producer as well as the government.

In recent times, the question of protection of data submitted to regulatory bodies for biologics has been litigated before courts. In a decision rendered on 25 April 2016, the Delhi High Court restrained a generic company which proposed to launch a biosimilar from using the data relating to manufacturing process, safety, efficacy and tests conducted by the innovator company to establish the safety of its biologic.

 

Packaging and labelling

18. Outline the regulation of the packaging and labelling of medicinal products.

Legislation and regulatory authority

The Drugs and Cosmetics Act 1940 (Drugs and Cosmetics Act) read along with the Drugs and Cosmetics Rules 1945, regulates the labelling and packaging of all medicinal products manufactured and marketed in India.

The Central Drugs Standard Control Organization monitors and sets out the labelling standards for medicinal products.

The labelling of medical devices must conform to the Indian Standards Specifications set out from time to time by the Bureau of Indian Standards, in addition to any other requirement prescribed under such rules.

Information requirements

Sections 94 to 109A of the Drugs and Cosmetics Act provide for the requirements and particulars that must be complied with during labelling and packaging of medicinal products, including homeopathic medicinal products, biological products and medical devices. The requirements prescribed are not exhaustive and include the following, which must be either printed or written in indelible ink and must appear in a conspicuous manner on the label:

  • The name of the drug.

  • Name, address of the manufacturer and the number of the licence under which the drug has been manufactured.

  • Batch or lot number.

  • Date of expiry, if any.

Further requirements include, for example:

  • A correct statement of the net content in terms of weight, measure, volume, number of units of contents and number of units of activity. The weight, measure and volume must be expressed in the metric system.

  • Package inserts must include such contra-indications, special warnings and special precautions for use, interaction with other medicaments and other forms of interaction, pregnancy and lactation, if contra-indicated.

  • Biological substances and other special substances that are advertised or sold as a proprietary medicinal product or contained in a medicinal product so advertised or sold, must have the proper name of the substance on the label in the manner prescribed.

Part XV of the Drugs and Cosmetics Act deals with labelling of cosmetics while Part XVII of the Drugs and Cosmetics Act deals with labelling of Ayurvedic (including Siddha) or Unani drugs.

Other conditions

All information is required to be printed or inscribed on labels, packaging and containers of medicinal products and must be in English and other local languages.

 

Product liability

19. Outline the key regulators and their powers in relation to medicinal product liability.

The Central Drugs Standard Control Organization (CDSCO) is the regulatory body for pharmaceuticals and medical devices in India. Headed by the Drugs Controller of India, the CDSCO has regulatory control over the import of drugs, approval of new drugs and clinical trials, and meetings of the Drugs Consultative Committee and Drugs Technical Advisory Board (DTAB). The DTAB consists of the Director General of Health Services, the Drugs Controller and a number of directors and presidents of the major research institutes, laboratories, and medical, pharmacy and drugs related councils.

An inspector duly appointed under the Drugs and Cosmetics Act 1940 (Drugs and Cosmetics Act) has power to inspect a medicinal product at any stage of the supply. This extends from a drug which is being manufactured to any person who is conveying or delivering such a drug to a buyer. If an inspector finds that any provision of the Drugs and Cosmetics Act has not been complied with, the liable person is criminally liable and can be punished with a fine and/or imprisonment.

The Quality Council of India is an autonomous body of the Department of Industrial Policy and Promotion, which has been created jointly with Indian industry. Its main activities are standards formulation, certification, laboratory testing, calibration and management, standards promotion and training, and international co-operation in the field of standards.

Under the Drugs and Cosmetics Act and Drugs and Cosmetic Rules 1945, there are:

  • Provisions for product recalls, complaints and adverse reactions (paragraphs 27 and 28, Schedule M).

  • Licence conditions for defective product recall (Rule 74(j) and Rule 78( i)).

To provide a uniform recall procedure, the CDSCO issued Guidelines on Recall and Rapid Alert System for Drugs (Including Biologicals and Vaccines) with effect from 23 November 2012. These guidelines apply to all quality defective product reports and to all reported incidents of safety and efficacy received for all drugs, including vaccines and biological drugs. The guidelines can be accessed at

www.cdsco.nic.in/writereaddata/Guidlines%20on%20Recall.pdf .

 
20. Are there any mandatory requirements relating to medicinal product safety?

The Central Drugs Standard Control Organization (CDSCO) is responsible for issuing mandatory steps for a manufacturer or any other person involved in the manufacture or sale of the medicinal product, to ensure that products are safe and comply with all necessary regulations.

The CDSCO has issued a Manual for Good Manufacturing Practices. It also publishes periodic safety alerts informing the public about drugs not safe for consumption, and compliance notifications by persons involved in the pharmaceutical and medical products industry. These can be accessed at www.cdsco.nic.in/forms/SearchMore.aspx?Id=33.

The CDSCO also publishes regulatory guidance documents to, for example, inform interested persons about licences required or specific requirements for performing clinical trials.

 
21. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.

Legal provisions

Liability for medicinal product liability law can arise under the following:

  • Tort law.

  • Consumer Protection Act 1986.

  • Drugs and Cosmetics Act 1940.

  • Contract law.

  • Criminal law.

Substantive test

The manufacture for sale or distribution, selling, exhibition, offer for sale and import of adulterated, counterfeit, spurious, misbranded or fake drugs, as well as drugs that do not conform to the standard of quality prescribed by the government, is prohibited and can expose the relevant party to liability.

 
22. Who is potentially liable for defective medicinal products?

The liable party depends on the law under which the product liability is sought to be imposed:

  • Tort law (the manufacturer of the medicinal product).

  • Consumer Protection Act 1986 (the seller, manufacturer, trader, service provider or any person who puts, or causes to be put, his own mark on any goods made or manufactured by any other manufacturer, provided the goods are sold or distributed with the mark).

  • Drugs and Cosmetics Act 1940 (the manufacturer, seller, stockist or exhibitionist of any spurious or adulterated drug or a drug that is not of standard quality).

  • Contract law (the contracting party is potentially liable for selling defective goods).

  • Criminal law (liability is imposed for commission of negligent acts that are likely to spread the infection of disease dangerous to life).

 
23. What defences are available to product liability claims? Is it possible to limit liability for defective medicinal products?

The following defences are available (although these do not apply to the drug manufacturer or the manufacturer's agent for distribution):

  • The claimant is not entitled to sue, due to reasons such as defective title.

  • The person acquired the drug or cosmetic from a duly licensed manufacturer, distributor or seller.

  • The import of patented products by any person from a person who is duly authorised under the law to produce and sell or distribute the product is permitted.

  • The person did not know and could not, with due diligence, have ascertained that the drug or cosmetic in any way contravened the law.

  • The trader could not have known, even after exercising due diligence, that the goods so offered were unsafe to the public.

 
24. How can a product liability claim be brought?

Limitation periods

The following limitation periods for bringing an action depend on the law under which liability is sought to be imposed:

  • One year from the date the injury arises (in tort).

  • Two years from the date the cause of action arises (under the Consumer Protection Act).

There is no period of limitation in criminal liability cases and cases under the Drugs and Cosmetics Act 1940.

Class actions

Class actions are permitted for product liability claims. Under the Consumer Protection Act 1986, a complainant can be any voluntary consumer association or one or more consumers, where there are numerous consumers having the same interest. Although there have been a few product liability cases involving class actions, they are not very commonly filed in India for product liability cases.

 
25. What remedies are available to the claimant? Are punitive damages allowed for product liability claims?

The punishments imposed for the sale of adulterated or spurious drugs including sub-standard drugs are as follows:

  • A period of imprisonment, no less than a term of five years and up to life imprisonment.

  • A fine that is no less than INR10,000 (section 27, Drugs and Cosmetics Act).

Further, under the Consumer Protection Act 1986, the Commission can order any of the following:

  • Removal of the defect in the goods.

  • Prohibiting the offer for sale of the hazardous goods.

  • Withdrawal of the hazardous goods from being offered for sale.

  • Compensatory and punitive damages.

 

Reform

26. Are there proposals for reform and when are they likely to come into force?

The Drugs and Cosmetics (Amendment) Bill 2013 was introduced in the Rajya Sabha (the upper house of the Indian parliament) on 29 August 2013. The Bill amends the Drugs and Cosmetics Act 1940 and changes the name of the Act to the Drugs, Cosmetics and Medical Devices Act 1940. Some features of the Bill concern treatment and compensation in case of injury or death during clinical trials. It also aims at establishing a Medical Devices Technical Advisory Board and a Drugs Technical Advisory Board. The Bill also seeks to ensure standards of quality for drugs, cosmetics, and medical devices.

The Biotechnology Regulatory Authority of India Bill 2013 was introduced in the Lok Sabha (the lower house of the Indian parliament) on 22 April 2013, which seeks to create the Biotechnology Regulatory Authority of India (BRAI). The BRAI will regulate the research, transport, import, containment, environmental release, manufacture, and use of biotechnology products.

On 23 March 2013, the Controller General of Patents, Designs and Trade Marks launched the Guidelines for Examination of Biotechnology Applications for Patents.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in India: overview ( www.practicallaw.com/3-566-3907) .

 

Online resources

Central Drugs Standard Control Organisation (CDSCO) of India

W www.cdsco.nic.in/forms/Default.aspx

Description. The official website of the CDSCO. It contains life sciences related legislation which is kept up to date.



Contributor details

Pravin Anand

Anand and Anand

T +91 120 405 9300
F +91 120 424 3056
E pravin@anandandanand.com
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Professional qualifications. Lawyer, India, 1979

Areas of practice. Intellectual property law.

Recent transactions

  • Involved in several areas of intellectual property law and practice, including mediation and advisory work.
  • Counsel in the first case in India to recognise moral rights of an artist, the first case on the principles of dilution.
  • Counsel where an Anton Piller order was issued for the first time in India.

Aditya Gupta

Anand and Anand

T +91 120 405 9300
F +91 120 424 3056
E aditya@anandandanand.com
W www.anandandanand.com

Professional qualifications. Lawyer, India, 2010

Areas of practice. Intellectual property law.

Aasish Somasi

Anand and Anand

T +91 120 405 9300
F +91 120 424 3056
E aasish@anandandanand.com
W www.anandandanand.com

Professional qualifications. Lawyer, India, 2013

Areas of practice. Intellectual property law.


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