Soon, uniform inspection norms for pharma units; govt to form advisory body

There may soon be uniform regulatory standards for manufacturing units of the pharmaceuticals industry in the country as the government gets ready to join the Pharmaceutical Inspection Cooperation Scheme (PICS). The government is trying to implement a uniform inspection standard, calling it the Indian Good Manufacturing Practices (GMP).

The PICS is an international instrument meant to improve cooperation in GMPs between countries and regulatory authorities.

About 7,000-odd small and large pharma manufacturing units, about 80 per cent of the industry, in India do not follow World Health Organization (WHO) GMPs. These would find it difficult to comply with Indian GMPs as well.

Sources in the government and the industry said this could lead to consolidation among smaller units. The government is also mooting a cooperative manufacturing model for small units.