The task force set up by the department of pharmaceuticals (DoP) under the Indian government banner to monitor the domestic pharmaceutical production, has expressed dissatisfaction over lapses in quality of home-made drugs.
The primary work assigned to the task force is to probe the allegations leveled against the manufacturing capabilities in India, and the initial report suggests quality lapses now.
This task force came into being in December 2014, and is headed by DoP secretary VK Subbaraj. It comprises of eight representatives from the ministry of health and family welfare, drug controller general of India, department of commerce, department of industrial policy and promotion, and industry associations.
The quality of manufacturing is also likely to adversely affect the exports as there is an increased scrutiny by the US Food and Drug Administration (USFDA) now. It poses a growing challenge for the India pharmaceutical industry.
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.”