India's digital national drug regulatory platform to be a reality soon, says DCGI

The long wait for a complete digital transformation of India’s national drug regulatory system could end as the government is likely to assign the task of developing and operating such a system to the eligible bidder soon. The very big and historic reform could completely change the face of Indian drug regulatory system, said Rajeev Singh Raghuvanshi, Drugs Controller General (India), Central Drugs Standard Control Organization (CDSCO).

Addressing the 8th CII Pharma & Lifesciences Summit in Delhi on September 18, Raghuvanshi said 12 companies including big ones had bid for this. “The technical presentations are over, and the financial bids will be opened in the next one week or 10 days. It has been planned for some time, but now it is going to start in the next one month”, he said.

According to him, the development of the new digital platform, the digital drug regulatory system, will be completely change the face of the drug regulatory system of the country.

Raghuvanshi listed out a series of reforms CDSCO has already carried out as part of its ‘ease of doing business’ measures to attract pharmaceutical R&D in India. The first and foremost reform taken to promote R&D and innovation was to free R&D from the need for regulatory approvals, he said. According to him, in most cases, there is no need for prior regulatory permission for conducting drug research in India. Instead, research can be initiated just by intimating about it through a designated portal. Simiarly, regulatory requirements to conduct bioequivalence studies have also been eased. “We are expecting lot of clinical studies to come to India after this reform”, Raghuvanshi said. He also added that 99% of the regulatory processes carried out by CDSCO today are in the digital mode.

The government has also given in-principle approval to create 1,500 new positions within the CDSCO to strengthen its internal scientific cadre who have the necessary skill sets to review new drug applications, and conduct regulatory audits of new therapies and medicines that require regulatory approval in India.

Speaking on the occasion, Manoj Joshi, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, said he is hopeful that in the next one or two months there will be a lot of changes in the regulatory system. He outlined a reform agenda spanning the RCGM approval process, state regulatory approvals, faster turnaround on queries and testing across institutions, and moving towards parallel processing, including allowing manufacturing without repeated inspections, rather than sequential approvals.

In her address, Suchitra K Ella, President-Designate, CII and Co-Founder & Managing Director, Bharat Biotech International Limited, highlighted the Government interventions such as Biopharma SHAKTI, with an outlay of ₹10,000 crore over five years, BioE3, and the ₹1 lakh crore Research, Development, and Innovation framework intended to bring greater private-sector participation into high-impact research. “India should increasingly aspire to be a technology developer and owner, not only a technology adopter or manufacturer," she said.