India’s regulatory environ getting transformed with digitization: Arun Mishra

Nandita Vijay, BengaluruThursday, May 18, 2017, 08:00 Hrs  [IST]

India’s regulatory environment is going through a metamorphosis with digitization driving transparency, accountability and quality in review practices, according to Arun Mishra, executive vice president, regulatory affairs, India sub-continent, GlaxoSmithKline Consumer Healthcare.

The country’s regulatory framework is evolving with efforts to comply with the global drug manufacturing norms. There is a surge in new business models like e-pharmacies, e-consultations and e-diagnostics. This makes the Indian regulatory authority devise norms for the new age practices, he added.

Mishra who was in Bengaluru for the two-day Topra India 2017 conference on ‘Building Regulatory Excellence said that the Indian regulatory framework is bogged down by  complex issues like approvals from multiple ministries and several rules. The focus is now moving towards adopting  quality scientific decisions in a transparent manner, ensure meeting  the indicated timelines, adopt risk-based evaluation and align with ICH guidelines.
“To this effect, we have seen a revision in the Drugs & Cosmetics Act, simplification and rationalisation of good manufacturing practises with expert committees formed to formulate norms for Over- the- Counter drug sale and amend the Drugs & Magic Remedies Act among others”, Mishra said in his presentation on ‘India’s regulatory framework and its role in the global environment’.

India is the pharmacy of the world for 200 countries. It accounts for 60 percent of the world vaccine supplies and anti retroviral drugs besides 20 per cent of the US prescription share. The country accounts for 73 percent of the finished formulations, 22 per cent of APIs, 5 per cent of Ayush, surgical and herbal products. India which has the been recognised for its capability in APIs and generic drugs is now moving on to manufacture biologicals.

Among the notable efforts on the national regulatory front are increase of its enforcement personnel strength from 111 in 2008 to 475 in 2017 and 1,500 by 2022. At least 200 Pharmacovigilance centres have been opened which will touch 1,000 by 2022. Around 60 per cent of the operations in the regulatory departments are via e:governance mode. From expansion of zonal offices to drug surveys to assess quality parameters, along with science-based norms for clinical trial approvals, with compensation system in place for casualty assessment, indicate the efforts made to achieve a global recognition in India’s regulatory system, he said.

From creation of online portal to issue of licenses and decentralisation of regulatory responsibilities to state drugs control departments along with mobile drug & food test labs which transmit automated alerts via SMS to steer rapid product recalls imply the creation of a transparent environment. India’s regulatory authority is also keen to partner and collaborate with its global counterparts to drive transparency and accountability, stated Mishra.