Drug Regulation framework is a necessity in any nation as all medicines carry some risk of harm. It is therefore essential to monitor their effects, both intended and unwanted, to get an evidence-based assessment of risk versus benefit. Read here to know all about drug regulation and the approval process in India.
The Indian pharmaceutical industry ranks third globally in volume, estimated to be worth $42 billion.
For a pharmaceutical company to offer a brand-new prescription medicine in India, DCGI (Drug Controller General of India) clearance is required. Before new pharmaceuticals and medical devices may be sold, they must first be approved by regulatory bodies from various nations or groups.
The drug controller general of India (DCGI) is the head of the Central Drugs Standard Control Organisation (CDSCO) in India. DCGI is the head of the pharma regulatory framework in the country.
Drug Regulation in India
Drug regulation and monitoring, also known as Pharmacovigilance is important in assuring the safety of medicines and protecting patients from harm.
CDSO headed by the DCGI is responsible for the drug regulatory framework in India.
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.
CDSCO has six zonal offices, four sub-zonal offices, 13 port offices, and seven laboratories under its control.
Major functions of CDSCO
- Regulatory control over the import of drugs
- Approval of new drugs and clinical trials
- Meetings of the Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB)
- Approval of certain licenses as Central License Approving Authority is exercised by the CDSCO headquarters.
- Import registration and licensing
- License approving of blood banks, LVPs, vaccines, r-DNA products, and some medical devices.
- Banning of drugs and cosmetics.
- Testing of new drugs
- Oversight and market surveillance through inspectorate of center over and above the state authority.
Under the Drug and Cosmetics Act, the regulation of the manufacture, sale, and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for the approval of New Drugs.
Clinical Trials in the country, laying down the standards for Drugs, controlling the quality of imported Drugs, coordinating the activities of State Drug Control Organisations, and providing expert advice to bring about uniformity in the enforcement of Drugs and Cosmetics The ct.
The Drug Controller General of India is responsible the for approval of licenses for specified categories of Drugs such as blood and blood products, IV Fluids, vaccines, and Sera.
Central Drugs Standard Control Organization Headquarters is located in New Delhi and functions under the Directorate General of Health Services.
Acts/rules related to drug regulation in India
- Drugs and cosmetics act, 1940
- Drugs rules, 1945
- Medical devices rules, 2017
- New drugs and clinical trial rules, 2019
- Cosmetic rules, 2019
Process of drug approval in India
A pharmaceutical company in India must have DCGI approval for selling a new prescription drug.
The pharma company can approach the government regulatory agency in the countries they seek to sell the drug.
- Different countries or blocs have separate regulatory agencies tasked with reviewing new drugs and medical devices before companies can sell them.
A drug approval process comprises various stages:
- application to conduct clinical trials
- conducting clinical trials
- application for authorising the marketing of the drug
- post-marketing studies
In India, first, a drug is tested on animals and the effectiveness of the animal model is assessed.
- If the results of the animal model are positive, the findings and study are sent to the DCGI office with a request for conducting human trials of the drug.
- At the DCGI office, a subject expert committee (SEC) evaluates the findings.
- If the finding is satisfactory, the company gets permission for human trials to determine safety, immunogenic, city, and efficacy.
The SEC meets regularly to evaluate the results of trials and recommends the authorization of drugs basis the results presented by the pharma companies in the three phases of human trials.
The state regulators are responsible for licensing the manufacture, sale, and distribution of drugs in their respective states or union territories.
They also conduct checks for counterfeit or substandard drugs while also monitoring the quality of drugs in the state.
History of drug regulation in India
The concept of pharmacovigilance in India was first proposed in 1986 with a formal adverse drug reaction (ADR) monitoring system.
In 1997, India joined the WHO Programme for International Drug Monitoring.
In 2004, the Central Drugs Standard Control Organization (CDSCO) established the National Pharmacovigilance Programme (NPVP)
- However, in mid-2009 the World Bank funding for the NPVP ended and the program was suspended.
Recognizing the need for improved ADR monitoring in India, the Government of India proposed to work on a new framework for the program.
The Pharmacovigilance Programme for India (PvPI) was launched on a national footing in 2010 by the Ministry of Health & Family Welfare.
In 2016 pharmacovigilance became a mandatory requirement under the Drugs & Cosmetics Act, which was amended to require all manufacturers and importers of medicines to set up pharmacovigilance systems within their companies.
Challenges in drug regulation
As with any industry seeking rapid growth and capture of international share, there are some recognized challenges and bottlenecks needing to be overcome to realize the growth potential. For India’s pharmaceutical industry, quality and regulatory challenges require attention.
- Absence of unified and interoperable labeling and identification standards.
- Lack of adequate testing facilities, inspection, and monitoring mechanisms.
- Absence of comprehensive databases to track and record violations, history, etc.
- With the ith lack of a stable policy environment and a defined pricing regime for pharmaceutical products, the market shows considerable fluctuations in drug pricing which is something that discourages critical growth investment in third-party drug manufacturing.
- With a wide range of third-party manufacturers for pharma in India, there’s a need for effective implementation of quality standards to ensure the delivery of reliable products to the consumer base.
Studies have shown that due to the lack of comprehensive quality control and insurance regime in the Indian pharmaceutical industry, India has undergone the highest number of FDA (Food and Drug Administration) inspections since 2009.
News on drug regulation
MoHFW is preparing a proposal to create a centralized system of drug registration under the Central Drugs Control Standard Organisation (CDSCO) to keep a close watch on drug quality.
- It involves repurposing CDSCO’s online portal Sugam which maintains quality checks on new drugs.
- This plan comes against the backdrop of a string of scandals abroad over toxic Indian drugs like cough syrups causing children’s deaths in Gambia and Uzbekistan etc.
Globally, it is evident that India’s pharmaceutical sector holds great power and development potential due to the country’s solid foundation in pharmaceutical third-party manufacture and the tenacity displayed particularly during the epidemic.
The bottlenecks faced by the Indian pharmaceutical industry currently include quality and regulatory challenges that can potentially restrict the projected growth of the industry over the coming year problems with standards and rules for drug regulation must be resolved quickly and effectively. To ensure the best pharma third-party manufacturing practices are followed, channels and dedicated platforms of communication between regulators and key stakeholders are first developed.
With the help of thoughtful policy development, quality assurance, and an effective drug regulations regime, India can truly leverage its talented human resource to expand at a global scale.
-Article written by Swathi Satish