According to a recent report in the Mint, the Drugs Technical Advisory Board (DTAB), a statutory authority under the Drugs and Cosmetics Act, 1940 was to meet this week to deliberate amongst other things, the possibility of a ban on a drug called Buclizine. This drug, which was initially introduced in India by a Belgian company called UCB Pharma, was then sold to an Indian company named Mankind Pharma.

Buclizine is the most potent reminder of the absolute lack of accountability at the Ministry of Health. Originally approved as an antihistamine (treating motion sickness and allergies), the government in 2006 mysteriously approved the drug for an additional indication – as an ‘appetite stimulant’ for children. In order to approve the drug for an additional indication, the drug regulator is required to review data from additional clinical trials to establish the efficacy of the drug for the new indication. Except, the allegation against Buclizine has been that there were never any clinical trials or studies to establish the drug’s efficacy as an appetite stimulant. Apparently, even Belgium, the country of origin of this drug, has not approved Buclizine as an appetite stimulant. In other countries like the US, the drug has been entirely discontinued for all indications.

The controversy surrounding Buclizine’s approval in India as an appetite stimulant is no secret. Some vocal sections of the medical community have been voicing their criticism against the use of the drug as an appetite stimulant since 2011. Then in 2012, the Parliamentary Standing Committee on Health & Family Welfare, in its 59^th report, slammed the regulator for approving the drug. The committee reviewed the status of this drug in other countries, the lack of clinical trials needed to demonstrate safety and efficacy and demanded an inquiry into how an approval was granted; it also recommended punishment for those who approved the drug. The committee concluded with the following recommendation to the government:

“The Committee is of the view that responsibility needs to be fixed for unlawfully approving Buclizine, a drug of hardly any consequence to public health in India, more so since it is being administered to babies/children. At the same time the approval granted should be reviewed in the light of latest scientific evidence, regulatory status in developed countries, particularly in Belgium, the country of its origin.”

The government promised an inquiry, which never took place even though in 2013 the Standing Committee “took serious umbrage” in its 66^th report to the Ministry’s dilatory tactics.

Finally, in 2016, almost 4 years after the Standing Committee red-flagged the approval, an expert committee called the SEC met on February 19, 2016 and held deliberations over the use of Buclizine as an appetite stimulant. Since the company marketing the drug was unable to present any clinical data to justify the use of the drug as an appetite stimulant, the committee recommended that the drug be discontinued as a therapy for this indication. A few months later, the DTAB met on June 27, 2016 and after considering the SEC’s report “endorsed the proposal for prohibiting the manufacture, sale and distribution of Buclizine for the indication “as appetite stimulant”. DTAB also set up another expert committee to examine the continued use of Buclizine for other indications.

These recommendations from the SEC and DTAB were more than sufficient for the Ministry of Health to issue an order under Section 26A of the Drugs & Cosmetics Act, 1940 prohibiting the use of the drug as an appetite stimulant. Yet, no such order was passed by the Ministry of Health.

Now in 2018, we are back to square one with the DTAB reportedly meeting once again to deliberate the issue of Buclizine. In the meantime, the company selling Buclizine has claimed a turnover of Rs. 14 crores from this product, selling 42 lakh tablets every year to unsuspecting patients.

If you think that courts will hold the government accountable, think again. I tried filing a PIL before the Supreme Court in 2016 raising a number of issues including the approval granted to Buclizine. I was told by the court that I was raising academic issues after which my lawyers withdrew the petition.

The case of Buclizine is open and shut – if there is no clinical data demonstrating the efficacy of the drug as an appetite stimulant, the drug should never have been approved in the first place. The fact that the drug continues to be available on the Indian market 6 years after a bipartisan Parliamentary Standing Committee rapped the Ministry on its knuckles is a sign of a deep-rooted rot in the Ministry of Health. Merely changing secretaries in the Ministry will not cure this rot. Repealing and replacing the Drugs & Cosmetics Act, 1940 to put in place a more transparent and accountable mechanism is the only solution.