Pills move through a sorting machine at a pharmaceutical plant in Andhra Pradesh, India. (Photographer: Sara Hylton/Bloomberg)

FDC Drug Ban: When Will The Indian Drug Regulator Start...Well, Regulating? 


The spotlight has been shone on the Indian pharmaceutical regulator recently with the issues regarding its handling of the Johnson & Johnson faulty hip implant and the hundreds of fixed-dose combination drugs that are irrational and should never have been approved for use in India.

These two recent incidents only highlight persistent shortcomings with the Indian regulator – regulations haven’t kept pace with developments in the healthcare sector and the regulator has been lax in doing its duty at virtually every stage, even when regulations have been available and lax enforcement threatened patients’ lives.

The CDSCO’s Failures

An earlier piece highlighted the deficiencies in the Drugs and Cosmetics Act and the poor enforcement by the regulator of its powers to ensure the safety of patients who have been affected by hip implant recalls.

If this author’s argument is not convincing read the Report of the Department Related Parliamentary Standing Committee on Health and Family Welfare (May 2012).

It observed;

  • Central Drugs Standard Control Organization acted more as a facilitator of the drug industry than as a protector of the consumer;
  • While approving new drugs reliance was placed on the opinions of experts which were drafted by manufacturers and experts obliged them by putting their signatures on these opinions;
  • Action should be taken against officials;
  • Experts acting unethically while giving opinion in favour of drugs;
  • There is collusion between drug manufacturers and Central Drugs Standard Control Organisation;
  • Drugs unlawfully being approved; and
  • Persistent insolence on the part of CDSCO and hopes that never again shall the Drug Controller General of India approve drugs in violation of law, that too for use in neonates and young children.
“The Committee is of the firm opinion that most of the ills besetting the system of drugs regulation in India are mainly due to the skewed priorities and perceptions of CDSCO.”   

The FDC Ban

Banning FDCs has been attempted since 2010 but it has been so poorly implemented that courts have overturned the ban on several instances and that continues now.

Even after the recent list of banned FDCs, the government recently notified 21 FDCs as “pre-1988 cleared by the Supreme Court”. These drugs were permitted to be sold even though they are clearly irrational and perhaps even harmful, a clear abdication of the regulator’s statutory duty to ensure only safe drugs are sold to patients.

The judgment of the Supreme Court in Union of India v Pfizer (2017) clearly and specifically permits the government to examine the need to ban these drugs. 

Pre-1988 drugs which are irrational (see, for example, Vicks Action 500 Extra and D’Cold which have the same ingredients) or harmful (Propyphenazone, an active ingredient in Saridon has been banned in several countries) are not immune from a ban – all the government needs to do is have an expert committee thoroughly review the data for all FDCs and find good reasons to ban them. Instead, the government took the easy way out and permitted them without any examination.

Unregulated Clinical Trials

After the courts and civil society raised the issue of clinical trials that were conducted in a dangerous and unregulated manner, the Prof Ranjit Roychaudury committee was constituted and delivered its report in July 2013. While some of the recommendations have been implemented in an ad hoc manner, comprehensive regulations have yet to be notified despite being shared for consultation in February 2018. Those regulations go way beyond clinical trials and deal with the drug approval process generally.

Unfortunately, those draft regulations require very low standards for FDCs to be approved and all the FDCs which have been banned could well have been approved under the new draft regulations. 

Status quo benefits the current players and change is disruptive to their business models. If patient safety is the objective, the regulator needs to wake up and make up for lost time. Courts, civil society and even Parliament has tried to nudge the drug regulator to perform its statutory duty. What more will it take for our drug regulator to, well, regulate?

Murali Neelakantan is an expert in healthcare laws.

The views expressed here are those of the author’s and do not necessarily represent the views of Bloomberg Quint or its editorial team.

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