Show cause notices issued by NPPA to drug makers

Show cause notices have been issued to 10 top drug makers in the country by the National Pharmaceutical Pricing Authority (NPPA), This has been done in the absence of submission of relevant information on the names of formulations, manufactured and marketed by them. Some of the prominent names in the category issued show cause notices include: Sun Pharma, Lupin and Aurobindo Pharma. Dr Reddy’s, Cipla and Cadila Healthcare are part of the top 10 list as well.

Sun Pharma and Lupin are India’s top two pharma companies by market value. Besides the big names, certain smaller pharma companies have also been issued notices on similar grounds.

Dr Reddy’s, Glenmark, Abbott, Cipla, GlaxoSmithline, among others, have denied having received intimation to this effect from the NPPA yet.

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, according to HT.

According to information revealed by Bhupendra Singh, NPPA chairman, 95 % of the drug makers in India have not complied with integrated pharmaceutical database management system (IPDMS). “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.” adds Singh.

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

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

In May last year, the NPPA 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 has made online submission of data mandatory for pharma companies.