FDA & PCB offices should be within Pharma Parks for speedy approvals: Experts

CII PHARMASCOPE: A Step Towards Atamnirbhar Bharat - Made In India, Made for the World’.

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Experts in the industry are of the opinion that the Union government should set up small offices of pollution control board and drug regulatory within the Pharma Parks to expedite the required clearances in a time bound manner.

Experts’ suggestion in this regard comes at a time when the government has recently made announcements to establish Pharma Parks at different locations in the country to incentivise and give a boost to domestic manufacturing of active pharmaceutical ingredients, key starting materials and intermediates in the country. The pharma industry sees the need for government departments of drug regulatory and environment control to be also stationed within the Pharma Parks as it would bring about ease of coordination and transparency.

Further, the industry sees the need for a world class Pharma Park infrastructure with uninterrupted power and water supply, allowing the companies to produce to their full capacities without interruptions of any sort and also be able to go through successful global audits, noted the pharma chiefs at a webinar ‘CII PHARMASCOPE: A Step Towards Atamnirbhar Bharat – Made In India, Made for the World’.

Also read: API mfrs seek support from govt, regulators

The government’s clarion call for a self-reliant India to stay away from imports must be converted into a viable and profitable opportunity, said Dr Dinesh Dua, chairman, CII Northern Regional Committee on Life Sciences and Biotech, chairman Pharmexcil & executive director, Nectar Lifesciences. The industry can optimise its techno-capability to manufacture not just paracetamol but other products as it did in the past. What China took 20 years to achieve, India can generate the momentum to become self-sufficient in APIs within the next 5 years, added Dr Dua.

Delving on the strategies to make India a global hub for API manufacturing, Dr S Eswara Reddy, joint drugs controller (India), CDSCO, said that any disruption of drug supply during this COVID-19 pandemic will adversely impact patient care. The reality is that India imports 70 percent APIs valued at Rs. 42,000 crore. Such excessive dependence on China is a concern. Moreover, China’s fluctuating and exorbitant pricing for APIs cannot be justified as it drained India’s foreign exchange and created  the balance of trade deficit.

“China has been able to monopolies the API market because of its massive manufacturing capacity, low cost of utilities and export incentives. Its interest rate is 4-6 percent as against India’s 8.5 to 11 per cent. Power tariff is Rs. 4 to 6 per KW and India’s is Rs. 7. In China, adoption of advanced technology is extensive while it is under-utilised in India. The effluent treatment plant (ETP) charges are Rs. 102 per KL against India’s Rs. 1,920 KL.

While China imposes a business tax of 25 per cent, India’s is 26-34 per cent. Further, in China industry-academia partnership is promoted with tax benefits to accelerate R&D, which is unheard of in India. Now in an effort to ensure Indian pharma capitalises its inherent strength, our government is now supporting end-to end manufacturing operations through Productivity Linked Incentives and bulk drugs parks, Dr Reddy noted.

The other members of the panel included B R Sikri, Co Chairman, CII Northern Regional Committee on Lifesciences & founder, ABS Group of Companies, VV Krishna Reddy, president, Bulk Drug Manufacturers Association of India, Arjun Juneja, director, operations, Mankind Pharma, Sanjay Suri, CMD, Morpen Labs and Pranav Gupta, co-chairman of PHD Chamber of Commerce & Industry and managing director, Parabolic Drugs.

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