Govt plans 'responsible person' at drug cos to hold accountable

Drugmakers may soon have to identify in-house point persons for authorities to communicate with and hold responsible for breaches, a government communication showed.

- Priyanka Sharma

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.