The Union Cabinet chaired by the Prime Minister Shri Narendra Modi has given its ex-post facto approval for the Memorandum of Understanding (MoU) between the Central Drugs Standard Control Organization (CDSCO), India and National Agency for Drug and Food Control (BPOM), Indonesia on cooperation in the field of pharmaceutical products, pharmaceutical substances, biological product and cosmetics regulatory functions. The MoU was on signed on 29th May, 2018 in Jakarta.
The MoU is expected to forge better understanding about each other’s regulatory requirements and would be beneficial to both the countries. It could also facilitate India’s export of pharmaceutical products.
It will also establish a framework for fruitful cooperation and exchange of information between the two countries in matters relating to Pharmaceutical products regulation on the basis for equality, reciprocity and mutual benefit. Further, it will facilitate better understanding between the regulatory authorities of the two countries.
The CDSCO is a Subordinate Office of the Directorate General of Health Services, which is an attached office of the Department of Health and Family Welfare and is the National Regulatory Authority for drugs, medical devices and cosmetics in India. The BPOM regulates these products in Indonesia. Approval of the Hon’ble Prime Minister had been obtained under Rule 12 of the Government of India (Transaction of Business) Rules, 1961 for signing the MoU by CDSCO (India) and BPOM (Indonesia).