Around 150 drug inspectors from western India recently underwent a training session at Gandhinagar to improve their inspection skills. It was not an isolated instance, as similar workshops are being organised across the country.
With 50 per cent of exports going to highly regulated markets, the pharmaceutical industry has geared up to boost compliance. Concerted efforts at the industry and government levels seem to be working. Last year, there were 192 inspections, while 29 per cent of the US Food and Drug Administration’s (USFDA) warning letters were issued to India. In 2015, there were 272 inspections and 50 per cent USFDA warning letters were issued to India.
Crisil, in a recent report, said the share of formulations exports to regulated markets (estimated to have dipped by 5 per cent in 2017-18) was expected to grow by 7 per cent in 2018-19. “Increased efforts towards remediation have also resulted in closeout of some regulatory alerts for big pharmaceutical companies in the last year. We expect this to continue in 2018 for some larger players, allowing companies to receive Abbreviated New Drug Application approvals of products stalled, owing to the alerts, thereby, improving exports,” it said.
The All India Drug Control Officers Confederation (AIDCOC) has organised workshops to train drug inspectors across the country. The Central Drugs Standard Control Organisation (CDSCO) is trying to make the Indian regulators match international standards through such training sessions.
The Indian Pharmaceutical Alliance (IPA), a group of leading Indian pharmaceutical companies such as Cipla, Lupin and Cadila Healthcare, had formed a quality forum in May 2015 with technical help from McKinsey and led by six chief executive officers. This forum developed guidelines for data reliability, investigations, process validation and good documentation practices. At a review meeting in February this year, the IPA found the efforts bore fruits.
“A review in February 2018 of outcomes achieved indicate that our efforts are bearing fruit and that we have been able to make every employee who we have touched conscious of quality and good manufacturing practices. The aim is total quality, and not mere compliance. We also worked on measuring effectiveness of what we were doing,” said D G Shah, secretary-general of the IPA.
The AIDCOC workshops are trying to plug the gaps that exist between industry and the regulators. Uday Bhaskar, director-general of the Pharmaceutical Export Promotion Council (Pharmexcil) who attended the Gandhinagar workshop, said it was important to continue the dialogue between industry and regulators and improve the understanding of quality assurance. “Almost 50 per cent of our exports go to highly regulated markets and it is important to ensure quality assurance at the manufacturing level,” he said.
State-level drug control administrations, too, have geared up to align themselves with global regulators. The Gujarat Food and Drug Control Administration (FDCA) signed a memorandum of understanding with the USFDA some months ago as part of the global harmonisation programme towards capacity building, training, networking, knowledge sharing and compliance. An FDA delegation comprising senior advisors visited Gujarat in December last year.
“The idea is to help our drug inspectors understand audit preparedness implemented in the regulated markets and help manufacturing units maintain compliance levels of global standards,” said H G Koshia, commissioner, Gujarat FDCA.