Retail chemists in Uttar Pradesh, Jharkhand, Bihar, Chattisgarh and Uttarakhand are facing acute shortage of Crocin Advance for the past two months despite manufacturer GSK's claim that it is in the process of rolling out fresh stocks of medicine following National Pharmaceutical Pricing Authority (NPPA) directive. NPPA had directed GSK to sell the drug in accordance to Drug Price Control Order (DPCO) following Maharashtra Food and Drug Administration (FDA) action on GSK for overpricing.
While a GSK spokesperson confirmed that they have started rolling out fresh stocks a fortnight ago owing to market demand, Crocin Advance is still being sold at the overpriced rate of Rs.30 per strip of 15 as the old stocks has not yet been recalled in states Chattisgarh and Tamil Nadu and in some parts of Delhi.
Febrex Plus from Indoco Remedies Ltd, Ultraflam from Ranbaxy, Dolo from Micro Labs and Calpol from GSK are being dispensed by chemists as substitutes to Crocin Advance. Crocin Advance is currently the fifth largest brand among top paracetamol-based products with annual sales of Rs.10.3 crore during the 12 months ending February 2014.
The shortage as it has been given to understand is due to the fact that GSK suffered huge loss in terms of profitability by complying to the price mandated by NPPA as against the overpriced rate. GSK launched Crocin Advance in 2011 claiming the product was a new drug, with optizorb technology which releases its medicine up to five times faster than ordinary paracetamol tablets, providing fast relief. On this basis, the company sought exemption from price control, while also contending Crocin Advance was developed through indigenous research and development (R&D). Under para 32 (iii) of the Drug Price Control Order (DPCO), 2013, a ‘new drug’ developed through indigenous R&D can be kept out of price control for five years.
The company had commenced a nationwide recall of its stocks of Crocin Advance following Maharashtra FDA stop sale order and NPPA's direction three months ago. GSK was expected to recall the entire stocks of Crocin Advance from the market and send back after relabelling it at the DPCO price of Rs.14.94 for a strip of 15 tablets in a short period. Now even after 60 days, the company could not complete the recall of the overpriced stocks.
Says a retailer based in Lucknow, "We are selling the drug at the old price since we have not received any intimation from the state drug regulatory authority or the company. We are therefore bound to sell at the old overpriced rate." Drug control departments in most of the northern states have, however, not issued any directions to sell the product at the DPCO price. These state administrations are stated to not have received any order from NPPA in this regard.
Retailers based in Mumbai have started selling the drug at the DPCO price of Rs.14.94 for a strip of 15 tablets as against the overpriced rate of Rs.30 for a strip of 15 tablets.