Bulk drug manufacturers seek support from govt, regulatory authorities

Suggest fast track regulatory clearance/approval, loan term extension etc.

Indian bulk drug manufacturers have requested the government and regulating authorities to bring some changes in the existing policies along with regulatory reforms to uplift the country’s API industry and work towards Aatmanirbhar Bharat

VV Krishna Reddy, President, Bulk Drug Manufacturers Association of India said, “The government has announced the bulk drug parks and production linked schemes to encourage the industry and make India self-reliant. However, there is a need to understand that the API manufacturing industry is capital intensive and the loan tenure period is for a maximum of five years. It takes a minimum of two years to set up a plant and another two years to get all the required approvals, therefore it is the need of the hour that the government makes a provision of minimum 10 years to repay the loan amount.”

He added, “During the COVID-19 crisis, the regulatory authorities have fastened up the approval process, which needs to be maintained in the future too.”

BR Sikri, Chairman, FOPE, and Vice President, BDMA said, “A majority of the API manufacturers are from the MSME segment. Since it is a cost-intensive sector, the government should extend the MSME term loan from five years to a minimum 10 years. Besides this, we also request the central and state-level pollution control authorities to monitor the effluents instead of monitoring the production.”

Referring to the tense border situation between India and China, he said, “Realising our considerable dependence on China for 53 APIs/ KSMs, the government has announced the production linked incentive (PLI) scheme. This will help the industry to increase production in the country itself. However, to secure the domestic industry involved in manufacturing of those 53 APIs/ KSMs, the government should consider imposing anti-dumping duties and encourage more industry-academia collaborations.”

Arjun Juneja, Director, Mankind Pharma commented, “To make the Indian API industry competitive and self-reliant, there is a need to initiate strategic planning. So, pharma companies, regulators and the government need to work together and adopt a collaborative approach. “

He added that there is a need to incentivise R&D programmes to accelerate research and development in the industry. He said that Indian scientists have capabilities but there is a need to work on a strategy for retaining them in the country to utilise their knowledge for our country and society’s betterment.

Sanjay Suri, Whole Time Director, Morepen Laboratories said, “In the proposed three bulk drug parks, we should design the facilities in such a way that any global regulatory authorities can conduct the audit/inspection.” He added, “Our Indian regulators should also have their offices within each bulk drug, which will ensure ease of doing business and also initiate necessary approvals and clearance on the fast track.”


APIsArjun JunejaBDMABR Sikribulk drug manufacturersFOPEMankindMorepen LaboratoriesSanjay Suriself-relianceVV Krishna Reddy
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