GlaxoSmithKline Consumer Healthcare has run into trouble with the drug regulator in Maharashtra over the company’s popular fever and pain medicine Crocin.
The medicine has not been available at local chemists after the Maharashtra Food and Drug Administration (FDA) sent GSK a notice for over-charging on the drug, and stopped supplies. Girish Vakharia, Assistant Commissioner (Bhiwandi), said the regulator has stopped supplies from the company’s main stockist for the State, located at Bhiwandi, on the outskirts of Mumbai.
The price of paracetamol is fixed under the Drug Price Control Order (2013), but GSK says its Crocin Advance is a locally-researched new drug, and, therefore, it is outside the ambit of price-control. The fixed price of paracetamol is 94 paise for a tablet (₹9.40 for a 10-tablet strip), Vakharia said, adding GSK sold Crocin Advance at ₹20 a strip.
The State regulator has written to the National Pharmaceutical Pricing Authority (NPPA) for clarity on whether the locally-innovated Crocin Advance should be exempted from price control. The authority’s clarification will be key to whether Crocin comes back on to chemist-shop shelves across Maharashtra.
However, if the NPPA agrees with the Maharashtra regulator’s view, it could result in a domino effect –other States may stop Crocin Advance at its present price.
Jayant Singh, GSK Executive Vice-President (Marketing), maintains that Crocin Advance (500 mg) was a local innovation that gave consumers faster relief than a regular paracetamol. The Drug Controller General of India had certified the product as a new drug, he said, adding locally-researched new drugs are exempt from price control. It has to do with interpretation, Singh said, with the company’s view being different from that of the Maharashtra regulator. The NPPA will give its ruling after discussions, he said, adding the company was also in discussions with various State authorities.
Media reports indicate that Kerala drug authorities, too, had stopped supplies of this drug for similar reasons late last year.
No shortagesThough the lower priced version of Crocin has been phased out, Maharashtra FDA’s Vakharia added that there was no shortage of paracetamol in the market, as several other brands were available at lower prices.