Domestic medicines face quality lapses, says govt task force

The task force is also required to identifying any such gaps in production of drugs in various therapeutic categories and suggests remedial action. In response to the matter, the panel has further advised that India should participate in the development of global regulatory standards.

“Storage and distribution under required conditions (temperature, humidity, sunlight etc) are not of desired standards, affecting quality of medicines ... there is lack of strict enforcement of regulations and quality measures,” the task force told HT.

Thirteen warning letters were issued last year to top pharma companies including Sun Pharmaceuticals, Wockhardt, Cadila Healthcare and Dr. Reddy’s. “Such regulatory actions hold potential to delay product approvals and launches in the US,” said the report by rating agency Icra.

“Capacity building should be done of not only pharma companies but also of regulators by organising workshops with regulators of other countries such as MHRA etc ... Quality control must be ensured and available drugs should meet prescribed standards.”