Question : Bulk Drug

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

(a) whether India was the world’s leading bulk drug manufacturer till about 10 years back and if so, the details thereof;
(b) whether overwhelming dependence on drug imports and related raw materials from China could prove harmful for the health sector in India in the long run;
(c) if so, the facts thereof and the percentage of the total requirement of drugs imported from China during the last three years, year-wise;
(d) whether the experts have expressed concern over the security risk and financial stress of the drug manufacturers of the country, if so, the details thereof and the reaction of the Government thereto;
(e) whether the Government proposes to revive the drug sector and introduce a bulk drug policy in the country;
(f) if so, the details and status thereof; and
(g) the time by which a final decision is likely to be taken in this regard?

MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY OF SHIPPING AND MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

(a): India has been importing Bulk Drugs/Active Pharmaceutical Ingredients (APIs) which are required for the manufacture of certain drugs including some essential medicines in the country.
(b) &(c): This occasion may not arise as most of the imports are done on economic considerations and there are other substitute suppliers for these APIs.

The details of India’s imports of Active Pharmaceutical Ingredients is as under:

Years Total import
(Rs. cr) Imports from China
(Rs. cr)
2014-15 19833.19 12757.96
2015-16 21225.97 13853
2016-17 18372.54 12254.97
(Source: DGCIS Kolkata)
As per the data of Directorate General of Commercial Intelligence and Statistics, (DGCIS) Kolkata, during the year 2016-17, the share of China in the total bulk drugs imported into the country was approximately 66 per cent.
(d) to (g): The Government, taking into account the drug security of the country, had set up a high level Committee on 8th October, 2013 headed by Dr. V. M. Katoch, the then Secretary, Department of Health Research, which had the mandate to carefully study the whole issue of APIs of critical importance by identifying important APIs and then working out a package of interventions/concessions required to build domestic production capabilities and examine the cost implications. The Committee has since submitted its recommendations. The recommendations were examined and it has been decided to finance common facilities in bulk drug parks which would reduce the cost of production and in turn it would reduce the cost of medicines which would be available to the patients. In this connection, the Standing Finance Committee (SFC) of Department of Pharmaceuticals had in its meeting held on 07.02.2018 approved the Scheme for Development of Pharmaceutical Industry which has ‘Assistance to Bulk Drug Industry for Common Facility Centre’ as one of its components. No separate bulk drug policy is proposed.

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