New Delhi: The Union government is drawing up an index to gauge states and union territories on their preparedness to enforce Central regulations on drugs, medical devices and cosmetics, according to officials and documents.
Drug regulator Drugs Controller General of India (DCGI) is finalizing the parameters for the index to be adopted by states and UTs. Currently every state and UT has its own set of regulations.
The goal is to make enforcement rational and transparent, and improve drug safety surveillance and standards.
“Right now, every State/UT follows its respective regulations and drug enforcement activity is uneven across the country. The system is not so strong. For instance- some Fixed Dose Combinations (FDCs) are being allowed in states which are not permitted by the Centre. Most of the states are not aware of the number of manufacturing and sales units in their jurisdiction. Dissemination of information is not very strong in Northeastern states. Therefore, there is work in plan to bring a Drug Regulatory Index for the State/UTs to get uniformity in enforcement practice,” one of the officials said.
This will bring transparency and increase the enforcement activity and improve the coordination between the Centre and the state governments,” the official added.
Setting up enforcement parameters
The Index will have a list of enforcement activities, such as the number of raids (on premises), enforcement staff, samples picked for testing, the number of samples that fail or pass tests, posts that are vacant or filled, resources, drug inspectors, and manufacturing and sales units.
“However, more parameters are being added,” the official added.
The decision was taken in a recent meeting of the drugs consultative committee (DCC) held in the central drugs standard organization (CDSCO) under the chairmanship of Rajeev Raghuvanshi, DCGI, in January.
“In order to ensure the effective regulation of medical products including drugs, medical devices and cosmetics, it is proposed to create a State Drug Regulatory Index to improve the standards of drug regulation across the country and enhance its global standing. The primary objective of the State Drug Regulatory Index is to enhance the effectiveness and uniformity of drug regulatory mechanisms across the country by strengthening drug safety surveillance, promoting accountability, fostering collaboration, enhancing resource utilization,” stated the minutes of the meeting.
The Indian pharmaceutical industry is the world’s third largest by volume of production and plays a significant role globally supplying cheap medicines.
DCGI will monitor the index
“There are some states which are doing work but some states do not have enough staff and resources. Not every state government is uniform. The idea is that every state government should follow the similar enforcement practice and make it more rational. The implementation of these indexes will be monitored by the DCGI,” said the second official.
Drugs and cosmetics are regulated under the Drugs and Cosmetics Act, 1940 which ensures safe and quality import, manufacture, distribution and sale of such products in the country.
Himachal Pradesh, Maharashtra, Gujarat, Andhra Pradesh, Hyderabad, Sikkim lead in pharmaceutical manufacturing and are thought to require greater safety surveillance and enforcement.
