India’s pharmaceutical price regulator has started the first ever “census” to map all drug makers in the country in terms of geographic spread, investments, research spending patterns and other details. The data generated is expected to help with policy decisions to govern a sector that is worth around Rs65,000 crore by sales.
The survey will also look at the use of price-controlled drugs by various manufacturing units to create so-called formulations or branded drugs and generate data down to the district level, in a bid to create the first robust database of allopathic drug makers in India.
The exercise will start this fiscal and conclude in 2008-09, covering more than 10,000 drug units of all sizes, said a top official of the National Pharmaceutical Pricing Authority (NPPA).
Drug makers said the survey would help benchmark their units. “The survey should throw up capability, capacity and standards of different manufacturing units across the country and that will be a useful guide. It should also look at the regulatory approvals of these units,” said Pankaj R. Patel, managing director, Cadila Healthcare Ltd and chairman of industry lobby India Pharmaceutical Alliance, referring to the compliance of what are called good manufacturing practices in the industry.
The results of the NPPA survey “will be published and circulated among the stakeholders,” NPPA chairman Ashok Kumar told reporters, adding that the watchdog will take action on any information from the survey provided it is under its purview; the health ministry can decide its course of action if some quality aberrations in drug manufacturing are found. The survey will cost Rs54 lakh,Kumar said.
Union minister for chemicals and fertilizers Ram Vilas Paswan said the drug regulator had received ISO 9001:2000 certification—an accreditation for quality management of processes. NPPA has often been criticized by the industry for its opaque style of functioning. Calling the certificate a “sign of transparency and foresight”, Paswan said NPPA had done a stellar job in tracking down violators and keeping drug prices affordable.
The drug price regulator has opened more than 700 consumer grievance centres and an online complaint filing system for citizens to flag cases of overcharging, the paucity of certain drugs and sale of medicine packs without NPPA’s approval.
A directory, which compiles names and contact details of 10,563 drug makers in the country, will help disseminate information to the public about pharmaceutical companies.