For drug regulation in a country as huge and diverse as India, effective execution cannot be done well with a total manpower count of 2000 drug regulators across the country and the only option was to free up resources for better and more effective execution, according to Rajeev Raghuvanshi, the Drug Controller General of India.
Speaking at the 10th Global Pharmaceutical Quality Summit, organised by the Indian Pharmaceutical Alliance in Mumbai on Thursday, February 27th, Raghuvanshi signalled the intent of the regulator to progressively move towards lighter regulation but effective execution. He pointed to several measures to create manpower capacity.
One is by forgoing the T-license requirement. These is the test license needed for import of small quantities required for clinical trials. The second area to free up regulatory manpower would be by coming up with a new system of Export NoC. He says typically between 2000 and 2500 export NoCs are issued every month only because regulations today say export NoC has to be quantity -specific and customer-specific. Therefore, depending on how many export orders a company has, it will need those many export NoCs. Instead, the drug regulator is now for a new system wherein an export NoC is issued for day one crore tablets for next one year and the company could export it to where ever it needs to but only keeps the regulator informed and the regulator will keep the database.
Also, there will be greater focus on digitisation with a digital drug regulatory system and a better database on value chain apart from developing internal scientific cadre. The regulator also spoke of involving outside professionals like independent auditors.
He also informed the industry representatives that they could expect further regulatory changes soon, including newer guidelines on cell therapy.
