PERSPECTIVE|COMMON DRUG STANDARDS
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Context
- The Union Health Ministry is considering formulating common standards for drug regulators at the Centre and the states.
- This will involve the harmonization of regulatory requirements, processes and procedures and databases across all states to ensure consistency in the evaluation and approval of drugs.
BACKGROUND
Present Drug Regulatory Framework in India
Who is the DCGI?
- 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.
What is CDSCO and what is its role in drug approval?
- The CDSCO is a central drug authority under the Ministry of Health and Family Welfare that regulates the quality, safety, and efficacy of drugs including vaccines as per the provisions of the New Drugs and Clinical Trials Rules, 2019, under the Drugs and Cosmetics Act, 1940.
- This organisation is the nodal authority for the approval of new drugs and clinical trials in the country. It lays down the standards for drug control over the quality of imported drugs.
Other Functions:
- The CDSCO also coordinates activities of several state drug control organisations and provides expert advice with a view to bringing about uniformity in the enforcement of the Drugs and Cosmetics Act.
- The CDSCO has the power to ban a drug that is considered harmful or sub-therapeutic under Section 26A of the act.
- It is also responsible for granting licences to government hospitals or medical institutions to import drugs for the use of their patients.
- CDSCO is also a nodal authority for registering foreign manufacturers of drugs and medical devices that they want to ship to India.
What role does the DCGI’s office play in the approval of drugs?
- The office of the DCGI acts as an appellate authority if there is any dispute with respect to the quality of the drug.
- The DCGI is also responsible for the approval of licences of specified categories of drugs such as blood and blood products, I V fluids, vaccines and sera.
Who does a pharma company approach before getting a drug onto the market?
- A pharmaceutical company in India must have DGCI 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 in.
- Different countries or blocs have separate regulatory agencies tasked with reviewing new drugs and medical devices before companies can sell them.
What is the process of drug approval in India?
- A drug approval process comprises various stages: application to conduct clinical trials, conducting clinical trials, application for authorizing the marketing of the drug, and post-marketing studies.
- In India, first a drug is tested on animals and the effectiveness in 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 them to be satisfactory, the company gets permission for human trials to determine safety, immunogenicity and efficacy.
- The SEC meets regularly to evaluate the results of trials and recommends the authorisation of drugs basis the results presented by the pharma companies in the three phases of human trials.
- Every country has its own regulatory authority that is responsible for enforcing the rules and regulations and issuing guidelines to regulate the marketing of drugs.
What do state drug controllers do in India?
- 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.
Why are regulatory affairs crucial for pharma companies before launching New Drugs?
- Following proper regulatory affairs at different phases of drug development, approval and marketing helps pharmaceutical companies to ensure the quality, safety, and efficacy of the drugs.
Pricing of Drugs
- The prices of drugs in India are regulated by National Pharmaceutical Pricing Authority (NPPA).
- To be precise, the NPPA regulates the prices of essential medicines.
- It further makes sure that the process of non-essential medicines are not too high.
Monitoring of Drug Safety
- The Pharmacovigilance Programme of India (PvPI) is responsible for monitoring the safety of drugs in India.
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What ails the Indian drug regulation?
No regular quality check
- There are many of structural issues affecting India’s drug regulatory system.
- They are instances of Indian pharmaceuticals and big companies often outsourcing their manufacturing to smaller units. This creates a bigger problem as the country lacks the resources to maintain a regular quality check on these products.
No statutory backing to CDSCO
- The biggest impediment to improving the quality of pharmaceutical regulation is the existing legal and administrative structures of the Central Drugs Standard Control Organisation (CDSCO).
- Unlike other regulators like the Telecom Regulatory Authority of India (TRAI) and the Food Safety and Standards Authority of India (FSSAI), the CDSCO does not have any statutory backing.
Lack of Transparency and the Complex Distribution of Regulatory Powers
- Additionally, the poor regulatory system is also plagued by a lack of transparency and the complex distribution of regulatory powers across authorities without much oversight.
Lack of Public Database
- There continues to be a lack of public databases on violations, inspections, and the history of a brand.
Proposals to improve the system
- In 2022, the Union government set up a seven-member high-level committee to prepare the first-of-its-kind 'National Drugs Database' in the country to provide comprehensive information about all drug formulations sold in India.
- The panel for the database has been constituted by the CDSCO under the Union Health and Family Welfare Ministry’s Directorate General of Health Services.
- In February 2023, Bharat Biotech suggested that all state drug regulatory bodies should be merged with the Central Drugs Standard Control Organisation (CDSCO) to ensure “one quality one standard” for Indian drugs.
What is the need of a Common Drug Standard?
No consolidated Public Database
- India does not have a consolidated public database that records the transgressions of each company licensed under the Drugs And Cosmetics Act.
38 Drug Regulators Today [Multiplicity]
- India has 38 drug regulators today — one for each state and Union Territory, plus the national regulator, Central Drug Standard Control Organisation (CDSCO).
- Each controller has its own network of laboratories to test drugs drawn from the market under its jurisdiction by its drug inspectors.
- Between the Union and the states, India has 37 drug-testing laboratories, yet laboratories of only three states — Gujarat, Maharashtra and Kerala — make their results available in a consolidated database.
No common set of standards. No collaboration
- India follows a system, where both Central and the state governments have important roles to play in issuing manufacturing licenses and regulating the drug sector.
- There is need for a common set of standards and regulations. This requires a significant collaboration from all stakeholders involved.
Impact of Drugs due to poor regulation
- In the past six months (Till March 2023), there have been at least three cases of deaths reported globally that are linked to drugs exported from India.
- Recently, a Chennai-based pharmaceutical company, Global Pharma Healthcare Private Limited, recalled a batch of eye drops from the US market after the US FDA said they were contaminated with a drug-resistant bacteria linked to permanent vision loss and had resulted in one death from a bloodstream infection.
- In December 2022 India launched an inquiry against the Noida based drug’s manufacturer, Marion Biotech, after the deaths of 18 children in Uzbekistan were linked to consumption of a syrup manufactured by the firm.
- In 2022, WHO issued a medical product alert over four cough syrups manufactured and exported by Haryana-based Maiden Pharma. At least 70 children died in The Gambia likely after consuming the said cough syrups.
There is a need to ensure that all manufacturing in the Country, whether it is by MSMEs or by India-based big drugs manufacturers, complies with Good Manufacturing Practices (GMP).
Common Drug Standards: Details
- The portal is being developed by the Central Drugs Standard Control Organization (CDSCO).
- The CDSCO is working with Ministry of Health and Family Welfare and other Government agencies, to ensure that the portal is integrated with existing regulatory frameworks and systems.
Key Features of the Common Drug Standards
Unified digital portal
- The Unified digital portal will bring together all stakeholders: regulators, manufacturers, distributors, state-run departments, and procurement agencies.
Database that is Centralized
- It aims to maintain a central database to better regulate the manufacturing, sale, and distribution of drugs.
Drug Safety Monitoring provision in the Portal
- The portal will include modules for monitoring drug safety and pharmacovigilance.
- The Portal will also facilitate the online submission of applications for various regulatory processes such as drug approval, clinical trials, and licensing.
Challenges
Health is a State Subject
- India is a federal state and health is a state subject; therefore, an idea like this would need everyone to come on board willingly.
Difficult to maintain a Centralized Database
- A central database will be difficult to maintain if states do not share accurate data in a timely manner.
- It will be a long-drawn process wherein enough awareness would need to be generated among states for their active participation.
Significance of Common Drug Standards
- The move could instill order and unify a fragmented system spanning 38 drug regulators, each with its own database.
- If a state drug regulator identifies violations by a drug company in the state, chances are, under the current system, knowledge of the same will not be shared with drug regulators in other centres or with the federal drugs regulator, the Central Drugs Standard Control Organisation (CDSCO). Once adopted and implemented, the new regime could help drug regulators across India know the credentials of all pharmaceutical companies and drugs at the click of a mouse.
CITATIONS:
https://www.business-standard.com/article/economy-policy/unified-national-portal-for-drug-regulatory-functions-in-the-works-123030800699_1.html
https://www.hindustantimes.com/india-news/govt-plans-common-drugs-standards-for-all-state-regulators-101678990617259.html
https://www.moneycontrol.com/news/trends/health-trends/all-you-need-to-know-about-drug-regulatory-framework-in-india-and-process-of-drug-approval-8715431.html
