Drugs and Cosmetics Rules 1945

Over the Counter drugs Regulations in India

Over The Counter (OTC) drugs are drugs that can be sold by pharmacists without a prescription from a Registered Medical Practitioner (RMP). Many drugs are sold over the counter without prescription, but the regulatory regime is grey in this regard, primarily because the term OTC has not been expressly defined under the Drugs & Cosmetics Act, 1940 (D&C Act) and the Drugs and Cosmetics Rules, 1945 (D&C Rules). Regulatory ambiguity is set to change, however, as the Central Government is now actively considering regulating the sale and distribution of OTC drugs[1].


Continue Reading Over The Counter Drugs – Regulatory Clarity on the Horizon

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.
Continue Reading New Drugs and Clinical Trials Rules, 2019 – A Regulatory Overview

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.
Continue Reading Medicines in Your Mail: The India Regulatory Story