The government is contemplating joining a global alliance of pharmaceutical regulators, a move that could help local companies scale up to international standards. The development comes even as Indian drug producers are facing heightened scrutiny for quality related lapses.
According to an official, the commerce ministry is considering options for an “observer status” in the Pharmaceutical Inspection Convention Scheme and Pharmaceutical Inspection Cooperation Scheme (PIC/S), a group of select global regulators that promotes uniform good manufacturing practices (GMP) across 45 nations.
PIC/S — as it is known in the industry — are two international instruments between countries and pharmaceutical inspection authorities to help them cooperate in GMP. Membership to these instruments is restricted to regulatory authorities.
While it would not enjoy the benefits of a participant or member, an observer status in PIC/S would give India’s Central Drugs Standard Control Organisation (CDSCO) a glimpse of the standards practised by drug inspectors in regulated markets like the US and the EU.
“(This move) will keep us in the loop and help us maintain (global) standards…a study is being conducted,” the official said.
CDSCO would be involved in the PIC/S secretariat proceedings, including any new rules and requirements for members, said Pharmaceuticals Export Promotion Council of India (Pharmexcil) Director General PV Appaji. “This would help India assess the situation to weigh the benefits (of joining PIC/S) against the problems associated with it,” he said.
The next step after an observer status would be CDSCO becoming a member of the PIC/S instrument. This could bring down the frequency of inspections by international drug regulators, many of which are part of PIC/S. “The general issues mid-level to top pharma companies have are that they are busy with too many audits,” said Appaji.
India is currently only looking at an observer status because its manufacturing standards and qualities are not uniform across its small, mid-level and large companies, according to the official quoted earlier.
“To become a member, the manufacturing facilities need to be upgraded, and that is something the small companies can’t do. Moreover, it takes 6-7 years for a country to become a member,” the official said. Industry representatives feel a move to become an observer in PIC/S could help bring the country’s pharma SMEs on a par with global standards, improving their export opportunities.
While industry experts feel India is capable of becoming a PIC/S member in the longer term, local regulators would also need to engage in adapting newer systems.
“CDSCO may have to take measures to fulfil PIC/S requirements such as its quality system, training of inspectors and must allow sufficient time for the national industry to comply with the PIC/S GMP guide,” said Ranjit Barshikar, a consultant on drug manufacturing.
“This is a long process for a large country like India, but it is a business opportunity for everyone in the Indian pharma sector,” said SV Veeramani, President of Indian Drug Manufacturers Association (IDMA), a local drug body. Currently, around 1,200 out of 8,000 SMEs adhere to WHO-GMP standards, according to him.
Source: The Economic Times
