Sun, Lupin, Aurobindo, others get show-cause notices from regulator

NEW DELHI: The National Pharmaceutical Pricing Authority (NPPA) has slapped show-cause notices on 10 top drugmakers, including Sun Pharma, Lupin and Aurobindo Pharma, for not submitting relevant information about the names of formulations manufactured and marketed by them. Besides these companies, notices have also been sent to a few other smaller firms.

Sun Pharma and Lupin are India’s top two pharma companies by market value.

Show-cause notices are generally issued by a court or a person in authority, which requires a party to appear and explain why a certain course of action should not be taken against it. If the party cannot convince the authority issuing notice or fails to appear, then the further course of action is taken.

In this case, the NPPA and companies are the party.

“Around 95% of drugmakers in India have not complied with integrated pharmaceutical database management system (IPDMS),” Bhupendra Singh, NPPA chairman, told HT. “The NPPA is now constrained to issue show-cause notices to individual companies for not having registered their products under IPDMS and for not having filed the mandatory returns in form II, III and V.”

The country’s 10 top drug makers include Sun Pharma, Lupin, Dr Reddy’s, Cipla and Cadila Healthcare, among others. “We have sent show-cause notices to all of them and it may take two to three days to reach them.”

Dr Reddy’s, Cipla, Glenmark, Abbott, GlaxoSmithline, among others, denied receiving any such intimation from the NPPA yet.

Sun Pharma, Lupin and Aurobindo Pharma did not reply to HT’s requests for comments.

Around 646 companies out of a total 5,000, and 56,400 formulations out of a total 1,00,000, have registered with the NPPA.

The drug regulator has sought detailed information for its latest online platform IPDMS, designed to monitor prices and availability of drugs across the country.

In May last year, the NPPA had issued notices to all pharma associations, warning them of ‘appropriate action’ against their member companies, who were yet to register into the same system.

The Drug Price Control Order (DPCO), 2013 makes online submission of data mandatory for pharma companies.