Institute of Good Manufacturing Practices India

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Indian pharma companies looking at WHO-GMP norms for quality standards

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. According to the Indian Drug Manufacturers’ Association (IDMA) the Centre is likely to incentivize the upgradation of Schedule M facilities to WHO-GMP compliant units through scheme of soft loans.

This move can see an extra 1,000 pharma manufacturing facilities, mainly small and medium enterprises (SMEs), to upgrade to WHO-GMP compliance within a year. The overall pharma contract manufacturing industry in the country is growing at 20 per cent. 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.

Another 1,000 units can easily upgrade themselves to WHO-GMP status within the next one year if the government incentive comes through. At present only 10 per cent of all manufacturing units in the country are WHO-GMP compliant. This presents a huge opportunity before the SMEs towards upgrading the manufacturing facilities to meet WHO-GMP standards.

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