Legal & Regulatory > India

An insight into digital health in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75. 151. Is the term ‘digital health’ defined in your jurisdiction? If no, how is the term generally understood? The term digital health is not specifically defined in India. It is generally understood to include tools and services that use information and…

An insight into medical devices in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.   1. Who are the regulatory authorities governing medical devices in your jurisdiction? The following regulatory authorities have jurisdiction over medical devices in India. The Drugs Controller General of India (“DCGI”) The Central Drugs Standard Control Organisation (“CDSCO”) State drug licensing authorities…

Cannabinoid drugs, medicinal cannabis & opioid drugs in India – a comprehensive legal overview. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.   CANNABINOID DRUGS Global Comment: For the purpose of this chapter, we will assume that Cannabinoid Drugs are preparations made out of extract or tincture of Cannabis. If a drug contains cannabinoids which have been…

An insight into biosimilars & biologics in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.   1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not regulated in the same manner as generic medicines in India. While biosimilars and generic medicines are classified as drugs under the Drugs…

The key facts about the localization in Indian Pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.   1. Are there any rules or regulations requiring and/or encouraging localization in your country? What is the legal framework defining these localization rules and policies? There are no specific legislations or regulations requiring and/or encouraging localization in India. The…

Want to know more about orphan drugs & rare diseases in India? Read on! Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 99.   1. What is the definition of Rare Diseases in your country? India does not have a definition of rare diseases. The National Policy on Treatment of Rare Diseases, 2020 (“NPTRD”), which is currently in…

Regulation of medical devices in India has speedily evolved in the preceding two years. Before the introduction of the Medical Device Rules, 2017 (“MDR 2017”), the regulation of medical devices and drugs was inextricably linked. In the 18 months since the MDR 2017 has come into force, the biggest challenge has been evolving unique enforcement protocols for regulating medical devices. In 2019, the Indian Government is stepping up to this challenge. By constituting a special vertical at the apex drug…

2019 so far has witnessed a lot of activity in the pharma space, so much so that the e-pharmacy saga – a pressing development towards the close of 2018 – has taken a temporary backseat this year. Instead, the new stars of 2019 so far have been price regulation and regulation of electronic nicotine delivery systems. 2019 also saw a significant piece of legislation introduced – the New Drugs and Clinical Trial Rules, 2019 – which has already begun making…

The Indian Government has had a busy 2019 so far with respect to healthcare regulation. From passing the controversial National Medical Commission Bill, 2019 through Parliament to releasing a digital health blueprint, the Indian Government has had a very clear vision for the future of healthcare in India. That vision largely focuses on health services being controlled and administered centrally, with states playing supporting roles in this process. The Government is also encouraging and regulating alternative forms of medicine such…

Anay Shukla leads the pharmaceutical, life sciences, med-tech and healthcare practice at Nishith Desai Associates, a leading Indian law firm. In this article, he examines the benefit of the recent policy changes to price controls for innovative drugs in India.  Unlike many other countries, India controls prices of all drugs sold in India.   Last month, India announced two key policy changes: First, that all patented new drugs would be exempt from all forms of price control that exist in…

Upcoming regulatory reforms affecting Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.   1.     Are there proposals for reform or significant change to the healthcare system? E-pharmacy regulations The Government has recently released draft regulations that propose to create a streamlined system of licensing e-pharmacies and governing the sale of drugs online. The rules grant legal recognition…

Vital info on patents and trademarks in Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.   1. What are the basic requirements to obtain patent and trademark protection? India’s Intellectual Property Law is TRIPS compliant. The Patents Act, 1970 and the Trademarks Act, 1999 provide protection and regulate patents and trademarks in India. PATENTS The requirements to…

An insight into product liability in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.   1. What types of liability are recognized in your jurisdiction? Manufacturers, distributors and retailers can be held liable either under D&C Act or under India’s penal laws. Generally, manufacture, import, sale of drugs and devices that are spurious or of poor quality or…

A guide to the legal requirements for traditional medicines and OTC products in India. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are categorized under the D&C Act broadly into Ayurveda, Siddha and Unani (“ASU”) drugs and Homoeopathic medicines. Ayurveda, Siddha…

An essential legal guide to marketing, manufacturing, packaging & labelling and advertising in Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? For information of the marketing authorization process for new drugs, investigational new drugs, investigational…