200 DRUGS FLOUTING PRICING NORMS: NPPA

The National Pharmaceutical Pricing Authority (NPPA), in an office memorandum, observed that pharmaceutical companies are flouting pricing norms by introducing new drugs without the regulator’s prior pricing approval. The NPPA’s notice to pharma companies also states these companies have introduced a number of Fixed Dose Combinations which are not approved by the Central Drugs Standard Control Organisation. The list includes 200 odd drugs and includes all major pharmaceutical companies. The regulator has asked companies to furnish details of batch-wise production and sales, along with the maximum retail price, certified by a chartered accountant.

In its show-cause notice to firms, National Pharmaceutical Pricing Authority (NPPA) has observed that many companies in India are flouting pricing norms by introducing drugs without its approval. NPPA’s list comprises 200-odd drugs, including fixed-dose combinations (FDCs), and all major pharmaceutical companies.

NPPA's show-cause notice said, "It is not clear whether these formulations have the approval of Central Drugs Standard Control Organization (CDSCO) and whether these are rational or irrational combination drugs, as many of them are FDCs."

NPPA notice to pharmaceutical companies accuses them of altering a formulation that comes under price control by tweaking the strength or dosage of the drug. NPPA can fix prices of any drug that comes under Schedule-I. NPPA can monitor the price of any drug that is non-scheduled. The NPPA can also ensure that prices of these drugs do not increase by more than 10 per cent annually.

The pharma pricing regulator has asked companies to furnish details of batch-wise production and sales, along with MRP (maximum retail price). In the notice, the state drug regulators have been asked to monitor unauthorised drugs being sold in the market.

NPPA has been cracking the whip on pharma companies, which have been allegedly flouting the price ceiling. In February, NPPA sent notices on overcharging in the case of 634 drugs. The number being high, the NPPA issued one show-cause notice. This time, too, NPPA has noted that the number is high, so it has issued only one show-cause notice.

Meanwhile, NPPA is monitoring the prices of medical devices such as heart valves, orthopaedic implants, and others.