INDIA Law and Practice Contributed by: Malathi Lakshmikumaran, Vindhya S Mani, Pallaash Shankhdhar and Khushi Lokwani, Lakshmikumaran & Sridharan Attorneys
bans the advertising of certain drugs and prohibits magic remedies or rituals claimed to cure diseases. • The Uniform Code for Pharmaceutical Market- ing Practices and the Uniform Code for Marketing Practices of Medical Devices are self-regulatory guidelines from India’s Department of Pharma- ceuticals (DoP) in order to curb unethical promo- tion, ensuring transparency and accountability by banning gifts, excessive hospitality and financial incentives to healthcare professionals, while man- dating declarations, compliance training and robust complaint/appeal mechanisms for both pharma and device companies. • The Drugs (Prices Control) Order 2013 (DPCO) is issued under the Essential Commodities Act, 1955 (ECA) to regulate the prices of prescribed essential medicines, in order to ensure their affordability and availability. The National Pharmaceutical Pricing Authority (NPPA) enforces these prices. Regulatory Bodies Under the Ministry of Health and Family Welfare • The Central Drugs Standard Control Organisation (CDSCO) functions as India’s National Regulatory Authority under the Directorate General of Health Services within the Ministry of Health and Family Welfare (MoHFW). It is led by the Drugs Control- ler General of India (DCGI), which oversees drug approvals and clinical trial regulation, and serves as the Central Licensing Authority (CLA). CDSCO establishes drug standards, monitors the quality of imported medicines, and works with State Drug Control Organisations (SDCOs/SLAs) to ensure uni- form enforcement of the DCA. In addition, the CLA, together with the SLA, issues licences for certain critical and specialised drug categories, including blood and blood products, intravenous fluids, vac- cines and sera. • SDCOs/SLAs are the primary regulators for the manufacture, sale and distribution of drugs and cosmetics within their respective states, func- tioning under the DCA. They are responsible for licensing, inspections and ensuring compliance with quality and safety standards at the state level. While SLAs operate independently under state governments, they co-ordinate with CDSCO/CLA, which provide national standards, expert guidance and oversight to promote uniform enforcement
of drug regulations. Advisory bodies such as the Drugs Technical Advisory Board and the Drugs Consultative Committee under CDSCO support this harmonisation by offering recommendations to both central and state governments. • The Drugs Technical Advisory Board (DTAB) serves as the apex statutory body for making techni- cal decisions on drug-related matters in India. As part of the CDSCO framework, it provides expert guidance to both central and state governments on issues concerning the DCA, and performs the responsibilities assigned under the Act. • The Drugs Consultative Committee (DCC) is another statutory body established under the DCA, designed to ensure uniform implementation of drug regulations nationwide by advising central and state governments along with the DTAB on all matters related to drug administration, quality and safety. It bridges the gap between central and state drug control authorities for consistent law enforce- ment. Primarily, it works on regulatory harmonisa- tion, including licensing, labelling, standards and related technical matters. • The Indian Pharmacopoeia Commission (IPC) is an independent body responsible for establishing standards for all drugs manufactured, marketed and used within India. IPC became fully operational in 2009 and is financed by the central government, with budgetary allocations under the administrative control of the MoHFW. It is considered to be India’s official body of standards for drugs, providing authoritative procedures, specifications for identity, purity and strength, and legally enforceable quality benchmarks for medicines manufactured, sold or distributed in the country. Under other ministries • The NPPA is an independent body, established in 1997 to regulate the prices of essential medi- cines, ensuring they are affordable and acces- sible to the public. The NPPA is a part of the DoP, which comes under the Ministry of Chemicals & Fertilisers. It fixes and revises drug prices under the DPCO and monitors drug availability, prevents overcharging by manufacturers, and advises the government on pharmaceutical policies. • The Central Bureau of Narcotics (CBN) is a central law enforcement and regulatory agency under the
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