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Gireesh Babu, New Delhi March 17 , 2022
The Department of Pharmaceuticals (DoP) has selected three agencies to work with the Government of India and submit reports on five studies on pharma and medical devices sectors in the country to help it frame policies, monitoring and corrective measures.

Initially, the agencies are selected for conducting one short term study and four long term studies related to these sectors under the Pharmaceutical Promotion and Development Scheme (PPDS) for the year FY 21-22, which is set up for promotion, development and export promotion in the pharmaceutical sector by extending financial support for conduct of seminars, conferences, exhibitions, and conducting studies and consultancies for the growth of the industry.

According to this, the short term study on Assessment of skill requirement of Indian pharma industry has been assigned to Himachal-Pradesh-based Biovantis Healthcare Pvt Ltd, an integrated healthcare product development company. The study is to identify the underlying factors with respect to the demand-supply mismatch as against opportunities for post graduates and doctorate holders from NIPERs in the Indian pharma industry.

The two long term studies - on Survey of Medical Devices Clusters and Pharma Clusters - and a survey for novel or innovative and cost-effective technologies for route of synthesis to decrease cost of production of active pharmaceutical ingredients (APIs) which are currently being imported to reduce import dependence are assigned to the Centre for Market Research & Social Development (CMSD), a research and consultation organisation established in the year 2000 and focusing on social research, development and market research mainly for government agencies in the country.

Another long term study, on the Strategy for leveraging ASEAN Free Trade Agreement and trade potential with the Middle East Countries for Pharma Sector in India will be conducted by the Institute for Studies in Industrial Development (ISID), a sponsored institution of Indian Council of Social Science Research.

The Department has invited sealed bids from reputed experienced empanelled agencies with Government of India to conduct long term and short term studies related to pharmaceutical and medical devices sector, through tender notice on October 22, 2021. These expert bodies are expected to help the government frame policies, monitoring and corrective measures in the pharmaceuticals and medical devices sector.

According to the Request for Proposals (RFPs) floated by the DoP, the two topics suggested in the short-term studies including the project assigned to Biovantis Healthcare has a duration of three months. The other short-term study DoP is expected to assign soon is on tracking of medicines across the supply chain.

The proposed surveys on medical devices and pharma clusters are within a timeframe of four months. The survey of medical devices clusters is to evaluate the industry’s contribution to overall production, supplies and exports, assessment of infrastructure and logistics framework and suggest improvements and providing recommendations to cost efficiency and cost competitiveness of clusters.

The survey on pharma clusters is to evaluate contribution of these clusters to overall production, supplies and exports, assessment of infrastructure and logistics framework and suggest improvements, provide recommendations to boost efficiency and cost competitiveness of clusters.

The survey for novel, innovative and cost-effective technologies for route of synthesis to decrease cost of production of APIs which are currently being imported to reduce import dependency, and expected to recommend on establishing industry-academia engagement and networking for development and commercialisation of API related technologies, has a timeframe of four months.

The study to develop a strategy for leveraging the ASEAN Free Trade Agreements and trade potential with the Middle East Countries for pharma sector in the country, which includes terms of reference to recommend strategies to leverage ASEAN FTA and potential trade with Middle East countries in fuller measure keeping in view the strengths of the Indian industry, is expected to be complete six months.

Out of the total eight studies for which the DoP has floated RFPs in October, five has been awarded to the research agencies now.

The other topics DoP is looking to commission studies, according to the RFPs, include a four month study on the impact of DPCO 2013 on the prices of cardiac stents, knee implants and six medical devices - oxygen concentrators, pulse oximeter, glucometer, BP monitor, nebuliser and digital thermometer on the industry and consumers in terms of availability and affordability, to assess the impact of price control on medical devices and equipment on the industry and consumers in terms of availability and affordability.

Another four month-study is for assessment of procurement of medical devices in the public sector (Central Government), to recommend regarding the medical devices for which the domestic value addition is less than 25 per cent and ways to improve the same.

Besides, a long term study for a timeframe of six months, is expected to be on the uniform code for pharmaceutical marketing practices, a study of Indian experiences as against best global practices, to recommend steps for better implementation of the UCPMP to achieve a more efficient outcome.

Yet another study, for six months, is an analysis on leveraging the patent cliff, with drug sales worth $251 billion going off patent as the pharmaceutical sector in the country will undergo landmark changes in the year 2021, as a number of drugs are expected to go off-patent and make entry in the market as generic products. The study is expected to recommend actions and roadmap for implementation with regard to each stakeholder to actualise the potential identified.

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