Who is responsible at drugmakers? Regulator wants to find out

livemint.com:

Drugmakers may soon have to identify in-house point persons for authorities to communicate with and hold responsible for breaches, a government communication showed. The apex drug regulator plans to order all drug companies to name a so-called responsible person (RP) who will be accountable for their day-to-day affairs, and serve as a single point of contact for state and central licensing authorities. On 16 December, drug controller general of India (DCGI) Rajeev Singh Raghuvanshi ordered the constitution of an expert committee to study the proposal.

“It is generally observed that in several cases, all the partners/directors, etc., are not responsible for the day-to-day affairs of the company. There is no documentation also to state that a person is responsible for the day-to-day affairs of the firm until claimed by the firm," said the DCGI communication, reviewed by Mint. Drug licences are issued to companies that may be constituted as proprietary firms, partnerships or private limited companies.

The licensee may have two or more partners or directors. The matter was first discussed at a meeting of the DCGI’s drugs consultative committee in September. The subcommittee proposed at the latest meeting will examine the matter and give its recommendations.

In the last year, some of India’s drugmakers have faced quality charges over cough syrups linked to the deaths of children in the Gambia and Uzbekistan. A government official said the move was prompted by difficulties in obtaining information on drug recalls and getting acknowledgment of drug inspectors’ notices, delaying investigations and punitive action. Companies often shift blame to avoid scrutiny, preventing the government from fixing responsibility and taking