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Drug Regulation

The Government’s attention has been drawn to a working paper series entitled “Poor Quality Drugs and Global Trade A Pilot Study” by Roger Bate and others of the National Bureau of Economic Research, published in September, 2014 which reported that India is supplying substandard medicines for markets with non-existent, under-developed or emerging regulatory oversight, notably Africa. The study is misleading. The extent of actual spurious/adulterated drugs is 0.27, 0.11, 0.16 and 0.11 percent for 2011-12, 2012-13, 2013-14 and 2014-15, respectively.       Drug-Regulation

Isolated reports of export of sub-standard quality of drugs by some Indian pharmaceutical companies have appeared in the media and on the websites of the regulatory authorities of foreign countries, etc., from time to time. As per the recent media reports, major regulatory actions taken against Indian Pharmaceutical Companies are as under:

  1. M/s. Aarti Drugs, Palghar, Tarapur, Maharashtra by United States Food and Drugs Administration (USFDA).
  2. M/s IPCA Laboratories plants situated at Pithampur, Indore, Madhya Pradesh  and Piparia in Silvassa by USFDA.
  3. M/s Suchem Laboratories, Ahmedabad by USFDA.
  4. M/s Emcure Pharmaceutical, Hinjawadi by USFDA.

For export of drugs, Indian Pharmaceutical companies are required to comply with the regulatory provisions of the importing country.

The Government does not have any proposal to disclose data in addition to what is already placed on the website of the Central Drugs Standard Control Organization. The Department of Commerce has conducted a study on Pharmaceuticals Inspection Cooperation Scheme (PICS). However, no decision has been taken by the Government to join PICS.

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