Pharma contract manufacturers seek WHO-GMP compliance

Apart from escalating demand by MNCs for contract manufacturing, Centre may incentivise upgradation of Schedule M facilities to WHO-GMP compliant units

As the share of multinational firms (MNCs) in pharmaceuticals contract manufacturing rises, more and more companies are looking at upgrading their facilities as per the World Health Organisation-Good Manufacturing Practices (WHO-GMP) norms to meet quality standards. What’s more according to the Indian Drug Manufacturers’ Association (IDMA) the Centre is likely to incentivise the upgradation of Schedule M facilities to  WHO-GMP compliant units through scheme of soft loans.

The move can see another 1,000 pharma manufacturing facilities, mainly small and medium enterprises (SMEs), to upgrade to WHO-GMP compliance within a year, IDMA feels. This would virtually double the existing number of such units in the country, currently pegged at around 1200 units.

The overall pharma contract manufacturing industry in the country is growing at 20 per cent, said S V Veerra Mani, president, IDMA adding that it offered a great opportunity for SMEs. At the moment, the size of contract manufacturing is estimated to be around 50 per cent of the domestic production or around Rs 35,000 crore.

Veerra Mani added that currently, MNCs enjoy around 20-25 per cent market share of the overall Rs 77,000 crore domestic pharma market, and nearly two-thirds of their production comes from contract manufacturing. “In short, the size of pharma contract manufacturing done by MNCs in India for the domestic market alone is around Rs 10,000 crore,” he said.

This presents a huge opportunity before the SMEs, and there is a strong traction towards upgrading the manufacturing facilities to meet WHO-GMP standards.

“The Centre is also planning to roll out a scheme to help SMEs to upgrade their Schedule M facilities to meet WHO-GMP compliance. This could be in the form of soft loans,” Veerra Mani said. He added that currently only 10 per cent of all manufacturing units in the country are WHO-GMP compliant, or around 1200 units.

“Another 1,000 units can easily upgrade themselves to WHO-GMP status within the next one year if the government incentive comes through,” he said.

IDMA has organised the fifth edition of the Pharmac India exhibition in Gandhinagar this year with the main aim to help SME contract manufacturers get a platform to connect with prospective businesses.