The drug regulator had issued an advisory on 9 Aug, mandating the 'product be used only under the supervision of a service provider and in a medical facility'
Mifepristone and Misoprostol are popular abortion pills
New Delhi: It will no more be easy to buy popular abortion pills Mifepristone and Misoprostol from your neighbourhood pharmacy, what with the government deciding to ban open retail sale of these drugs.
Citing rampant misuse, as specified under the Medical Termination Pregnancy Act 2002 and MTP Rules 2003".
However, in its recent Drug Consultative Committee (DCC) meeting held on 20 August, the drug regulator instructed the state drug controllers to impose a restriction on the sale of these drugs. "The wholesalers shall supply the kits only to the recognized centres to prevent the misuse of the kit," said the minutes of the DCC meeting. Mint has reviewed minutes of the meeting.
These are well-known pregnancy termination prescription drugs and, at present, can be procured from a pharmacy by furnishing a prescription. However, according to the state drug controllers, the drugs are misused by young women and can cause serious side effects, which in extreme cases may even turn fatal.
Earlier, the state drug controller of Haryana had raised a concern after which the drug controller decided to restrict its sale," said a person aware of the matter. According to another person, the drugs have been used as means to sex selective abortions too and hence it was felt necessary to put an end to the misuse of the drugs. Haryana, in fact, has been infamous for sex-selective abortions and infanticide. With 789 girls per 1,000 boys, it had the second-worst SRB in 2001, according to the census data. The ratio remained unchanged over the next decade.
The DCC, under the Drug Controller General of India (DCGI) V.G. Somani, decided that an advisory should be circulated to all manufacturers, and all state drug controllers. They have also been asked to include the prescribed conditions issued as advisory as a condition while granting licenses to the manufacturers.
“All state drug controller may interact with all the stakeholders for making awareness about the advisories issued by the drug controller general of India specially Chemist and Druggist Association, manufacturers and other relevant player," added the minutes.
Top drug firm Cipla dominates the combined abortion pill segment and is home to the brand leaders in the category of MT pill and the decision by the DCC may dent the MT pill market.