The event will also see introduction of digital tools for effective regulation. (Representational)
The Union Health Ministry will organise a two-day 'Chintan Shivir' from February 26 to explore ways to build trust on Indian drugs, cosmetics and medical devices in domestic and export markets and strengthen the regulations to ensure their quality, officials said on Tuesday.
The Chintan Shivir on 'Drugs: Quality Regulations and Enforcement' holds significance against the backdrop of questions being raised about the quality of some Indian drugs amid instances of Global Pharma Healthcare recalling entire lots of eye drop linked to vision loss in the US and India-made cough syrups being linked to children deaths in Gambia and Uzbekistan.
At the two-day event to be organised in collaboration with the Department of Pharmaceuticals in Hyderabad, experts and officials will review the predictability, transparency and accountability in the regulation of quality of drugs, ensure compliance to Indian pharmacopoeia standards and develop robust network for pharmacovigilance and materiovigilance programmes, the officials said.
The event will also see introduction of digital tools for uniform and effective regulation.
"The aim is to build trust and confidence on the quality of Indian drugs, cosmetics and medical devices in the domestic and global markets.
"Experts will also deliberate on effective enforcement at the field level for ensuring quality, safety and efficacy till the last mile. Discussions will focus on the present enforcement mechanism in place to address spurious, adulterated and substandard drugs, and the necessity for greater coordination between the states and the Centre in this regard and the issues and challenges in enforcement," an official said.
The shivir will also deliberate on creation of a unified IT platform for all regulatory activities such as an online National Drug Licensing Portal (NDLS).
The Central Drugs Standard Control Organisation (CDSCO) is the regulatory authority and under the Drugs and Cosmetics Act and rules made thereunder, it is responsible for approval of new drugs, conduct of clinical trials, control over the quality of imported drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bringing about the uniformity in the enforcement of the said Act, the official explained.
The Drugs and Cosmetics Act, 1940 and rules made thereunder have entrusted various responsibilities to Central and state regulators for regulation of drugs and cosmetics. It envisages uniform implementation of the provisions of the Act and rules for ensuring the safety, rights and wellbeing of patients by regulating the drugs and cosmetics.
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