At present, these early pregnancy termination drugs can be legally procured from pharmacists by furnishing a prescription.
The government has cited indiscriminate and rampant use of the drug without proper medical supervision as the reason behind the proposed ban. While the use of such drugs without caution can cause serious side effects such as bleeding from uterus, which in extreme cases may turn fatal, the government also fears that these drugs are being misused in parts of the country to conduct sex-selective abortions in late stage pregnancies, for which they are not even indicated.
The move, if implemented, can sharply dent the market of these two drugs which was roughly around R235 crore for the year ending July 2012, according to pharma market research firm Aiocd Awacs. Of this, top drug firm Cipla dominates the combined abortion pill segment by commanding a lions share of R100 crore.
Cipla is home to two brand leaders in these therapeutic categories MT Pill (mifepristone) and Misoprost (misoprostol).
Other top drug firms which market leading brands in these therapeutic segments include Zydus Cadila and Mankind. Both of these firms earn in the range of R43 to R45 crore annually from the brands they sell in these verticals. While Zydus Cadila is home to leading brands Mifegest and Cytolog, Mankind owns Unwanted and Prestakind. Rival peers Sun Pharma, Lupin, Alkem, Piramal Healthcare also have some presence in this niche space. However, a few of the firms also market their brands as therapy for a specific type of gastric ulcers.
The decision to tighten channels of distribution for these drugs was agreed to after a near consensus emerged on the issue in the Drug Consultative Committee, headed by the Drug Controller General of India (DCGI).
This issue was brought to fore by Gujarat Food and Drug Administration (FDA) commissioner Hemant Koshia and many other state FDA commissioners echoed similar concerns," said a government official. This decision would now have to be vetted by the Drug Technical Advisory Board, the apex body in the drug space, before getting notified.
A senior executive at a pharma firm in the supply chain department said some of these drugs are sold to pharmacies at the rate of R35 to 50, which in turn sell it at printed MRP of R350 to 500. This offers scope for exorbitant margins to retailers in some of these drugs, and this could be one reason behind brisk business in these drugs, he said.
FDAs in states such as Gujarat and Maharastra have clamped down on the practice of chemists illegally doling out abortion pills at their discretion without asking for prescription.
The Maharastra FDA, for instance, insists that chemists must preserve not only the prescription but preserve whereabouts of the buyers.
Chemists often crib that customers are hesitant to share personal information while buying abortion pills and pass on fake names and addresses, over which they have no control.
Such FDA drives in select states could partly be reason because of which the market for these abortion pills shrank by 17% in the 12 months period ended July 2012 compared to a similar period ended July 2011, even as the R60,000 crore domestic drug market grew by over 15% during the comparable period.