Drug regulator plans 'Responsible Person' in pharma firms
The Drug Controller General of India’s (DCGI) move has been prompted by difficulties in obtaining information from companies with many shifting the blame to avoid scrutiny and hence it becomes difficult to prosecute the companies in court.
The Indian drug regulator plans to order all pharma companies to name an in-house ‘responsible person’ (RP) accountable for day-to-day affairs and to serve as a single point of contact for both state and central licensing authorities.
The Drug Controller General of India’s (DCGI) move has been prompted by difficulties in obtaining information from companies with many shifting the blame to avoid scrutiny and hence it becomes difficult to prosecute the companies in court.
The DCGI move is in line with multiple measures taken by the government to crack down on poor compliance after several incidents of substandard cough syrups being linked to the deaths of children in Gambia and Uzbekistan rocked the pharma industry.
The RP will be the point person who will help with information on products licensed to the company, manufactured by it, and data routinely sought by the authorities.
Meanwhile, a Reuters report stated that India is close to finishing a probe into a ‘comprehensive and exhaustive’ complaint that a state drug regulator, in return for a bribe, helped switch samples of cough syrups linked to deaths of children in Gambia before the samples were tested in India.
The WHO linked syrups made by India’s Maiden Pharma to the deaths of 70 children in Africa last year. The Indian government said tests in an Indian lab showed the syrups were not toxic. Maiden Pharma has said they have not done anything wrong.
(Edited by : Ajay Vaishnav)
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