Q&A: the promotion and sale of pharmaceuticals and medical devices in India

Advertising and promotion

Regulation

Summarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?

Pharmaceutical advertising is governed by the following legislation:

• the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 (the DMR Act), which controls the advertising of drugs;
• the Drugs and Cosmetics Rules 1945, which regulate the labelling and branding of pharmaceutical products, cosmetics and homeopathic medicines in India;
• the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 (the IMC Regulations), relating to ethical conduct that may affect the relationship of medical practitioners with the pharmaceutical industry;
• the Uniform Code of Pharmaceutical Marketing Practices (the UCPMP Code), a self-regulatory code adopted by the Indian pharmaceutical industry; and
• the Code of Pharmaceutical Marketing Practices of the Organisation of Pharmaceutical Producers of India.

Medicinal products

The promotion of medicinal products in India is primarily regulated by the DMR Act and its associated Rules. The DMR Act stipulates that any advertisement of a drug that suggests or leads to the use of a drug for the diagnosis, cure, mitigation, treatment or prevention of any disease, disorder or condition specified in its schedule is prohibited in India. At the time of writing, the schedule under the DMR Act contains 54 diseases. A recently proposed amendment to the DMR Act proposes to expand the list to 78 diseases.

The DMR Act provides exceptions where the advertisement of drugs is allowed, including:

• where a registered medical practitioner’s signboard on his or her premises indicates treatment for any disease, disorder or condition;
• any treatise or book dealing with diseases from a bona fide scientific or social standpoint;
• any advertisement sent confidentially to a registered medical practitioner; and
• any government advertisement, or an advertisement by any government-sanctioned person.

Corporate or financial information describing a company’s area of business and progress in research falls outside the purview of the DMR Act’s definition of advertisement, as it does not constitute promotional claims on drugs as such. Further, it is common practice in India for pharmaceutical companies to advertise their area of business, infrastructure and research capabilities, among others.

In respect of online advertising, the DMR Act defines an ‘advertisement’ as ‘any notice, circular, label, wrapper, or other document, and any announcement made orally or by any means of producing or transmitting light, sound or smoke.’ These regulations are technically applicable to online advertising as well.

Another recent development in this regard is that the Ministry of Health and Family Welfare (MOHFW) introduced the Draft DMR Act (Amendment) Bill 2020 (the DMRA Bill) in February 2020, which proposes to include online advertising under the definition of advertisement under the DMR Act. In particular, the DMRA Bill proposes to include the following means of promotion under the definition of advertisement: ‘any audio or visual publicity, representation, endorsement or pronouncement made by means of light, sound, smoke, gas, print, electronic media, internet or website and includes any notice, circular, label, wrapper, invoice, banner, poster or such other documents’.

Medical devices

The MOHFW issued a notification on 11 February 2020 (the MOHFW Notification), specifying that the medical devices listed in the MOHFW Notification shall be treated as drugs as of 1 April 2020. Therefore, all the regulations and compliance requirements applicable to the advertising of drugs are also applicable to medical devices. The MOHFW Notification stipulates that medical devices include instruments, apparatuses, appliances, implants, materials or other articles, including software or accessories, for the purposes of:

• diagnosing, preventing, monitoring, treating or alleviating any disease or disorder;
• diagnosing, monitoring, treating, alleviating or providing assistance for any injury or disability;
• investigating, replacing or modifying or supporting the anatomy or a physiological process;
• supporting or sustaining life;
• disinfecting medical devices; or
• controlling conception.

Inducement

What regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?

The legal framework surrounding inducements to healthcare professionals in India is covered under the IMC Regulations and the UCPMP Code. The IMC Regulations and the UCPMP Code prohibit any inducements to healthcare professionals to prescribe, sell, supply or recommend the use of a particular medicinal product and, under the MOHFW Notification, these restrictions apply to medical devices as well.

Further, the UCPMP Code prohibits pharmaceutical companies from extending to healthcare professionals any travel facilities inside or outside the country, including rail, air, ship and paid vouchers, among others, as well as any hospitality services, accommodation, or cash or monetary grants.

Additionally, the standard Indian laws against corruption and bribery will apply to violations of the IMC Regulations and other legislation, such as the DMR Act and the Drugs and Cosmetics Act 1940 (DCA), and will also be applicable to healthcare professionals. Further, healthcare professionals in violation of these laws will be prosecuted under the applicable penal laws in India.

Reporting transfers of value

What requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?

There are no specific statutory requirements that apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices in India.

Enforcers

Describe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.

The food and drug administration authority in each Indian state is responsible for enforcing the DCA and the DMR Act.

Further, compliance under the UCPMP Code is enforced by the ethics committee for pharmaceutical marketing practices (ECPMP). The ECPMP has three members who will preside over a complaint. In the case of a review, there will be a five-member review committee named the apex ethics committee for pharmaceutical marketing practices (AECPMP), the decision of which will be final.

Sanctions

What are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?

Breach of the DMR Act provisions is punishable by up to six months’ imprisonment and a fine. There is up to one additional year of imprisonment for a repeated offence.

The UCPMP Code, which is a self-regulatory code, prescribes any of the following penalties in the event of a breach:

• suspension or expulsion of the company from the pharmaceutical association;
• reprimand of the company and publishing of the details of the reprimand;
• requirement of the company to issue a corrective statement in the media used for promotion; or
• requirement of the company to recover items given in violation of the UCPMP Code from the concerned persons and provide details of the action to the ECPMP or the AECPMP.

Sale and supply

Regulation

Are there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?

The Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945 (DCR) govern the sale of all kinds of drugs, including Ayurvedic (traditional medicines), Siddha and Unani (herbal medicines), and homoeopathic drugs in India.

Online supply

What laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?

There is no Indian law that regulates the online sale and supply of medicines and medical devices.

However, the Ministry of Health and Family Welfare (MOHFW) has issued a draft notification to amend the DCR to regulate the online sale of drugs, which, as at August 2022, is pending approval from the government. The draft notification prescribes a procedure for e-pharmacy registration for the sale and distribution of drugs through the e-pharmacy portal, a procedure for sale and distribution by verification of e-prescriptions, e-pharmacy portal monitoring and similar provisions.

Pricing and reimbursement

What are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?

The pricing of medicines in India is controlled by the Drug (Price Control) Order 2013 (DPCO). These pricing regulations are also applicable for medical devices in accordance with the MOHFW’s notification issued on 11 February 2020.

The following are some of the key pricing obligations under the DPCO on the importers, manufacturers and marketers of medicines and medical devices:

• The maximum retail price (MRP) of the product must not be increased by more than 10 per cent within any 12-month period. If the MRP of the product has been increased by more than 10 per cent, the importer, manufacturer or distributor will be liable to pay the overcharged amount along with penalty and interest thereon from the date of the price increase.
• All importers, manufacturers and distributors must submit the price revision of the product to dealers, retailers, hospitals and the government in Form V, prescribed under the DPCO.
• The National Pharmaceutical Pricing Authority (NPPA) has the authority to fix the ceiling prices of medicines and medical devices under extraordinary circumstances and in the public interest. Once the price is fixed, importers, manufacturers or distributors must fix the MRP to a price equal to or below the ceiling price.
• The ceiling price for the medicines and medical devices listed in the National List of Essential Medicines is fixed by the NPPA.

India does not have a mechanism for the reimbursement of drugs.