Drugs and Cosmetics Act 1940

New Drugs and Clinical Trials Rules, 2019 – A Regulatory Overview India 

Issues around payment of compensation in cases of clinical trial related injury, disability and death have long remained open. Despite a directive from the Hon’ble Apex Court, much was left open to question. On March 19 of this year, the Ministry of Health and Family Welfare (MoHFW) eventually took steps in this regard and notified the New Drugs and Clinical Trials Rules, 2019 (NDCT Rules) under the aegis of the Drugs and Cosmetics Act, 1940 (D&C Act), thus bringing an end to a long-drawn-out process to codify the rules applicable to clinical trials.
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Ban on advertising of Ayurvedic drugs

The Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) vide notification G.S.R. 1230(E) on December 21, 2018 has notified the Drugs and Cosmetics (Eleventh Amendment) Rules, 2018 (Amendment) ,which was subsequently published on December 24, 2018[1]. This Amendment seeks to regulate advertisements of Ayurvedic, Unani and Siddha drugs (ASU Drugs) in an attempt to curb misleading advertisements.

This step has been taken in light of the government’s reaction to the recent increase in the number of misleading advertisements relating to ASU Drugs. In 2017, the Ministry of AYUSH stated that it had signed a Memorandum of Understanding (MoU) with the Advertising Standards Council of India (ASCI), a self-regulatory organisation for the advertising industry, to monitor misleading advertisements being published in print and TV media.[2]
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Online Pharmacy Regulations in India

The Indian Pharmaceutical industry is in its prime phase of growth today at 11-12% per year. While exports occupy a huge chunk, the country meets nearly 95% of its own domestic demands through indigenous production and the domestic retail market is growing by leaps and bounds.

Sale of drugs in India is currently governed by the Drugs and Cosmetics Act, 1940 (D&C Act) and the Drugs and Cosmetics Rules, 1945 (D&C Rules). At present, the law permits sale of drugs through brick-and-mortar pharmacies only. The law as it currently stands is somewhat out of tune with the times in that it is still to catch up with the concept of online sales of drugs.
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