High level political interference, purportedly at the behest of some of the big pharma companies with vested interests, has come in the way of banning of some of the most controversial drugs, including the non-steroidal anti-inflammatory drug nimesulide, which were found to make adverse effects on human health.
Highly placed sources in the union health ministry said that the ministry has put on hold drug controller general of India (DCGI) Dr Surinder Singh's recommendations to ban four of the most controversial drugs nimesulide suspension, gastroprokinetic agent cisapride, decongestant drug Phenylpropanolamine (PPA) and human placenta extracts on political interference.
Sources said that DCGI's recommendation to ban these drugs has been put on hold by the health ministry after some Parliamentarians from Bihar wrote to the union health minister Ghulam Nabi Azad asking him to reconsider the ban on nimesulide on the plea that the sudden withdrawal of this medicine will adversely affect the patients. Sources also said that senior BJP leader Murli Manohar Joshi is the latest to join the bandwagon of MPs who are objecting to the ban of nimesulide, which is often described as the “dirtiest drug” in the market for its damaging side-effects on the liver.
Experts say that Alkem Laboratories, headquartered in Mumbai with strong roots in Bihar, will be the biggest loser if the nimesulide suspension is banned in the country as it is the biggest producer of nimesulide suspension with a sales turnover of more than Rs.13 crore which constitutes 4.4 per cent of Alkem's annual sales, experts said. Though Dr Reddy's was also a producer of nimesulide, it had stopped producing the suspension for over a year. Though other companies like Panacea also produce nimesulide suspension, the marketshare of these companies is insignificant.
Earlier in December last year, the DCGI had recommended to the health ministry to ban these drugs after the drugs technical advisory board (DTAB), the highest decision-making body under the union health ministry on technical matters, which has been examining these drugs, recommended to ban these drugs in the country due to the adverse effects of these drugs on human health.
Earlier last year, the DCGI had decided to put these controversial drugs under the radar of the DTAB in the wake of serious concerns raised by the medical experts in the country over the side-effects of these drugs.
Based on the recommendation of the DTAB and his recommendation to the health ministry, DCGI Dr Surinder Singh during his visit to Mumbai on January 7 this year had publicly announced that “Accordingly, a notification to ban these drugs will be issued in another 10 days or so”.
But, political interference has put paid to his recommendation to ban these drugs which have been found to have adverse effects on human health.
After the interference of the MPs, the Union health ministry asked the DCGI to review the matter once again and a review meeting was held on January 27 this year in which some of the manufacturers of nimesulide and members of the DTAB were invited.
Sources said that both the sides stuck to their earlier point. While the manufacturers argued that the drug is safe, DTAB members stuck to their earlier findings that the drug will have adverse effects on human health and should be banned for use for below the age of 12.