The controversy over the abortion pill Mifepristone in the US is being followed by gynecologists and a host of Indian companies who make generic versions of the drug.  

It is a move back to the dark ages, said Shantha Kumari, in terms of women’s right to their own reproductive health. Calling it an unfortunate turn of events, she said there was no safety concern about the drug and several local companies were making generic versions of the drug. Kumari is an honorary treasurer of the International Federation of Gynaecology and Obstetrics (FIGO), which represents national Ob-Gyn societies from about 130 countries. The medicine is given to women in hospital settings, she said, urging people to discuss their concerns with their doctor.  

Earlier this month, a controversy erupted involving Mifepristone, when a Texas Court Judge suspended the US approval given to this drug. Subsequently, the US Department of Justice has appealed this decision. In fact, about 300 pharmaceutical companies, too, have come out in an open letter against the Texas decision, and in support of the US Food and Drug Adminsitration’s authority to regulate medicines.  

Overturned FDA approval

“On Friday, April 7, a federal judge with no scientific training fundamentally undermined the bipartisan authority granted by Congress to the Food and Drug Administration to approve and regulate safe, effective medicines for every American,” said the letter. District Judge Matthew Kacsmaryk issued a decision that overturned the FDA’s 23-year-old approval of Mifepristone, the primary medicine used in abortion and miscarriage care, “which has been proven by decades of data to be safer than Tylenol, nearly all antibiotics and insulin”, said the letter signed by pharma industry representatives, including Pfizer Chairman and Chief Executive Bourla.  

Pointing out that the decision set a precedent for diminishing FDA’s authority over drug approvals, the letter said: “As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.”  

In India, Mifepristone is an estimated ₹200-crore market, while the kit, including Mifepristone and Misoprostol is pegged at about ₹400 crore, said an industry insider. A host of drugmakers make this drug or kit, including Cadila Pharma, Mankind, Macleods Pharma, Intas, Zydus Cadila, SunPharma and Cipla, to name a few. Concerned over the inter-connected nature of such developments, an industry-voice hoped the politically-tinged development in the US did not spill into other regions, including India.