With respect to Mutual Recognition Agreements (MRA) signed by India with its trading partners, how long does the Indian Designating Authority typically take to communicate its decision on the applications for registration of conformity assessment body to its MRA partner?
Reply: There is no specific time frame fixed. However, we always endeavour to take decision in the shortest time possible.
Singapore 11:
On the WTO Secretariat report (WT/TPR/S/249, page 113, para 248 260) that focuses on patents, we would like to seek clarification on whether there is a need for approval of marketing plans for (i) patented and generic drugs; and (ii) medical devices in India. If there is a need, we seek India's elaboration on the procedures for seeking approval.
Reply: There is a mandatory provision of registration of imported products before they are sold in the country. However Singapore should elaborate what do they mean by marketing plans for giving further clarifications.
Singapore 12:
We would like to seek clarification with regard to the registration procedure for pharmaceutical products in India.
With regards to the registration of western medicinal products (pharmaceutical drugs), are such registrations done at the central government level, i.e. by Central Drugs Standard Control Organisation (CDSCO) or by the respective health authorities within each district in India?