The task force formed by the Indian government to probe the string of allegations on drugs manufactured in India has found lapses in quality of domestic medicines.
The department of pharmaceuticals (DoP) had set up the task force on development of manufacturing capabilities in pharmaceutical production in December 2014.
“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.
The panel, which is headed by DoP secretary VK Subbaraj, has also found that unethical administrative clearances or inspections act as a hurdle to manufacturing.
The task force, which comprises 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, is tasked with identifying gaps in production of drugs in various therapeutic categories and suggest remedial action.
Greater scrutiny over quality standards by the US Food and Drug Administration (USFDA) is emerging as a key challenge for the India pharmaceutical industry.
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.
{{/usCountry}}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.
{{/usCountry}}The panel has advised that India should participate in the development of global regulatory standards.
“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.”