The National Pharmaceutical Pricing Authority (NPPA) has asked the pharmaceutical manufacturers to submit information regarding production and supply of scheduled medicines under 28 and 29 of Drug Price Control Order (DPCO), 2013 to ensure the availability of essential drugs in the country.
The NPPA's action in this regard comes following reports that there are severe shortages of some essential drugs in the country as the manufacturers have drastically reduced production of these medicines due to profitability and other reasons.
“The DPCO, 2013 has been enacted under section 3 of Essential Commodities Act, 1955 to ensure that essential medicines are available at affordable prices to all. In few instances, it has been found that manufacturers had done drastic reduction in production and supply, thereby creating shortage in availability of life-saving and essential medicines which is detrimental to the larger public interest.
“In order to avoid sudden shortage in availability of medicines listed in Schedule-1 of the DPCO, 2013 and to facilitate appropriate and timely measures that can be undertaken, all manufacturers of such medicines including manufacturers or importers of individual active pharmaceutical ingredients or bulk drugs as the case may be, are hereby directed to report to National Pharmaceutical Pricing Authority (NPPA) whenever production and domestic supply of such medicines/APIs falls below more than one third of average batch size production or domestic supplies in the last six months”, said the NPPA in its office memorandum addressed to all pharmaceutical companies and all pharmaceutical associations.
It may be recalled that recently there were reports that the pharmaceutical market in the country was facing severe shortage of life-saving drug D-Penicillamine which is prescribed for Wilson’s disease which is a rare and potentially fatal genetic disorder that causes excessive accumulation of copper in vital organs like the eyes, liver, kidneys and brain. The disease could even cause liver failure if left untreated, leaving the patient in need of a transplant. The availability of the drug is very important as there are no alternatives for the treatment of Wilson’s disease in the country, forcing the DCGI to step in to resolve the issue.
According to reports, the drug has disappeared from the market in the recent past and it is no more available in the country. It was also mentioned that at present the availability of bulk drug is also an issue as the suppliers of the drug’s most crucial raw material are now favouring other markets for better margins.