Drug price watchdog, National Pharmaceuticals Pricing Authority has threaten to take action against country’s top drugmakers including Abbott Healthcare, Mankind Pharma, Cadila, Lupin and Biocon. NPPA has found around 200 new drugs which are either being sold by drug makers without applying for price approvals or have been tweaked to escape the provisions under drug price control order (DPCO). It is also unclear whether these formulations have been approved by Central Drugs Standard Control Organization, national drug standards regulatory body. The safety and efficacy of those 'new drugs' is also under scanner as it is unknown whether they are rational or irrational combination of fixed doses.
“It has been decided to take action against these pharmaceutical companies…The concerned companies are required to furnish batch wise production and sales details along with the corresponding MRPs…” reads the office memorandum issued by NPPA on Wednesday evening. The OM shall be considered as show-cause notice only as authority would not issue the individual notices due to the paucity of manpower.
Moreover, new drugs are the altered versions of scheduled formulations with tweaked dosages or strengths than the specified or are made with combination of non-scheduled formulations.
NPPA has clearly mentioned that if the authority failed to receive the replies in about one month, it will take further action.
However, industry says that no company sells the drug without getting approvals on safety and efficacy of drugs from drug controller general of India or state licensing authorities. “NPPA has no power to decide whether the drug is approved, rational or irrational as no company can sell drug without obtaining license from the required authorities,” said S. V. Veeramani, an immediate past president of India Drug Manufacturers Association (IDMA), an association which represents domestic drug majors such as Sun Pharmaceutical Industries, Cipla and Lupin, among others.
