Sixty small drug makers have joined a government scheme that promises financial incentives for modernising their units in keeping with Indian attempts to sync with global good manufacturing practices. The move comes after a string of Indian-made drugs in regions as far afield as North America, Africa and Central Asia were found to be toxic, causing fatalities and raising questions about Indian pharma exports. Over 30 firms have already started upgrading their manufacturing units under the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS).

The Centre last year revised the Drugs and Cosmetic Act to make it mandatory for companies to follow World Health Organization-recommended good manufacturing practices (GMP).

“To help smaller plants, the scheme is facilitating existing pharma units to upgrade to revised standards. A portal has been opened wherein 60 plants have registered on it and they are being trained or assisted to follow GMP rules and upgrade themselves and 30 plants have already started their operations in terms of upgrading their facilities," said an official aware of the matter on the condition of anonymity. “The government is encouraging more such plants to come and join the scheme and take benefit in terms of upgrading themselves," the official said. The scheme gives preference to micro, small and medium enterprises (MSMEs), supporting smaller players achieve hig standards. Queries sent to the department of pharmaceuticals spokesperson remained unanswered till press time.

Incentives as per eligibility Pharma firms which have had an average revenue of less than Rs 5 billion over the last 3 years are eligible for incentives of a maximum of Rs 10 million per unit. Firms with an average revenue of Rs 10 million to less than Rs 500 million will get paid 20% of investments. Firms with a revenue of Rs 500 million to less than Rs 2.5 billion are eligible to 15% of investment while those with revenue of Rs 2.5 billion to less than Rs 5 billion are eligible for 10% of investment. They must invest in ‘eligible activities’ including heating, ventilation, and air conditioning, water and steam utilities, testing laboratories, stability chambers, clean rooms, effluent treatment, waste management etc. More firms will join in the coming days “Most of the companies that have registered are are MSMEs and more are likely to join soon. GMP compliance is of the highest standards and that is why it is taking time for companies to upgrade their facilities. It is easier to start a new factory than to upgrade the existing one. We are educating our member companies on GMP standards as the new guidelines have undergone drastic changes this time," said Harish K Jain, president, Federation of Organisations of Pharmaceutical Entrepreneurs (FOPE).

(Source: Mint)