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Our fight to stop pharma companies from selling banned and unsafe drugs in India

Date : 21/01/2019

The case pertains to the ban on 344 fixed dose combinations (FDCs) which includes widely popular drugs like Saridon, and skin cream Panderm, antibiotic Lupidiclox and combination diabetes drug Gluconorm PG among others, imposed by the Government in 2016 based on the suggestion of an expert committee which deemed these combinations unsafe and irrational. Pharmaceutical companies who sell these combinations have since left no stone unturned to challenge the ban in manner that can only be called abrasive (and through litigation that can only be termed vexatious).

This complex case is best understood through a timeline of events:

March 2016: Government bans 344 FDC’s on the ground that they involve ‘risk’ to humans and safer alternatives were available based on the recommendations of the Kokate Committee. Subsequently, pharma companies selling these drugs challenged the ban in the High Court.

December 2016: The stay is confirmed by order of the Delhi High Court. The argument given by the Delhi High Court for quashing the ban was that the Drugs Technical Advisory Board (DTAB) was not Consulted.

December 15, 2017:
All India Drug Action Network (AIDAN) along with other health rights organizations take the matter to the Supreme Court through an SLP (Special Leave Petition) and the Court on 15th December, 2017 rules that there is no need for the government to
consult the DTAB for exercise of powers to prohibit (ban), restrict or regulate under Section 26A of the Drugs and Cosmetics Act. Having stated this, the Court refers the Kokate report to the DTAB or an expert committee and mandates them to explicate the recommendations of the Kokate Committee on each of the 344 (plus five FDCs added later.)

February, 2018: The government appoints another expert committee to look into the Kokate Committee recommendations. The DTAB Subcommittee is headed by Nilima Kshirsagar, National Chair of Clinical Pharmacology, Indian Council of Medical Research (ICMR), and other subject medical experts, persons with impeccable scientific credentials.

August 2018: The DTAB Subcommittee upholds the recommendations of the Kakote Committee and recommends that 343 FDCs plus restriction/regulation on another six FDCs be banned. Immediately, manufacturers of the banned FDCs approach the Delhi High Court questioning the logic, legality, and raison d’être of the ban. Delhi High Court decides to relook into the the recommendations of the DTAB Subcommittee and re-examine the call for ban based on two aspects; whether a particular explanation in the report recommending ban on a FDC is logical and whether the subcommittee has applied its mind as evidenced by formulations recommending the ban.

January 2019:
Deciding over a batch of FDCs used for endocrine disorders, Justice Bakhru deems all but one drug combination unfit for re-evaluation by the DTAB committee, thereby upholding the ban on all but one FDC used for endocrine disorders.

Certain drugs/FDC’s are deemed unsafe and irrational in the following cases:

Drugs with potential safety risks
Drugs that lack evidence of effectiveness
Health fraud drugs
Drugs that present direct challenges to the new drug approval and over-the-counter (OTC) drug monograph systems
Drugs that are reformulated to evade enforcement action

The market for unsafe, irrational FDCs in India is at least one-fourth of the total pharma market which is valued at Rs. 1.3 trillion.

Lawyers associated with HRLN represent All India Drug Action Network (AIDAN) against the pharmaceutical companies selling the banned FDC’s.

Watch this space for the latest updates on ‘Dangerous drugs that are unfit for use but continue being sold in India’. Please find attached below, orders on the case.

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