Regulation of pharmaceutical drugs in India
The regulation of the pharmaceutical drugs is a very important aspect for a country to save its citizen from consuming harmful drugs which contain toxic impurities, drugs with unrecognized severe reactions, adulterated drug products, and counterfeit drugs.
In India, Drug regulation managed by the law of the Drugs and Cosmetics Act of 1940 was originally known as the Drug act, (this act was prepared under the recommendations of the Chopra Committee formed in 1930), and the Drugs and Cosmetic Rules, 1945.
Under this act pharmaceutical drugs are being regulated by the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, Ministry of Health & Family Welfare, and State Drug Regulatory Authorities (SDRAs).
Drugs regulation comes under the concurrent list of the 7th schedule of the constitution of India, so regulatory authorities are at both the central and the state level.
Central Drugs Standard Control Organisation (CDSCO)
At the center level, Center Drugs Standard Control Organisation regulates all work related to pharmaceutical drugs, it sees the uniform implementation of the provisions of the Act and Rules. This bodywork under the Ministry of Health & Family Welfare.
CDSCO has always been constantly thriving to bring the following-
- Transparency, Accountability, and Uniformity in services
- To ensure safety, efficacy, and quality of medicals product
- To see manufacturing, import, and distribution in India
- Responsible for approval of New Drugs and laying down standards for Drugs
- Conduct Clinical Trials
- To coordinate the activities of State Drug Control Organizations by providing expert advice to bring uniformity
The Drugs Controller General of India (DCGI) is the key regulatory authority, head of the CDSCO. Dr. VG Somani is current DCGI, responsible for the approval of licenses of specified categories of drugs such as blood products, IV fluids, vaccines, and serum.
The CDSO has been acting under the advice of the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC) which is its advisory body. It operates through its different zonal offices present across our country, where each one has to carries out pre-licensing and post-licensing inspections, post-market surveillance, drug recalls, and also has designated roles in drug regulation, like inspections, recalls, and market surveillance.
State Drug Regulatory Authorities (SDRAs)
At the state level, State Drug Regulatory Authorities (SDRAs), which are statutory bodies created under the Act, under the purview of their respective Health Departments of the state. SDRAs are tasked with limited aspects of drug regulation, its main duty is to regulate licensing of sales and manufacturing units within their jurisdiction and to maintain a check on the quality of drugs and medical equipment being manufactured.
As India is known as the pharmacy of the world and still, we have many concerns to address related to pharmaceutical Drugs regulation
Some of the problems which can be highlighted are-
- Center and State have inadequate numbers of drug inspectors
- No databases of errant drug manufacturers
- The overall lacking capacity leaves them incapable to enforce recalls and punish violators
- Poor communication between Center and States drug regulatory bodies compounds the problems
The Pharmaceutical industry has been growing due to the advancement of technology and the incresaing need for pharmaceutical drugs, challenging regulatory bodies. Questioning whether the Indian regulatory framework will manage to adapt to the changing needs of the market. To meet the regulation act needs to be implemented correctly, the gap between the Center and State needs to decrease, and a well holistic approach is much needed to keep up with the tag.
Thank You
Sources-
- https://en.wikipedia.org/
- https://www.britannica.com/
- https://cdscoonline.gov.in/