Medicines and other drugs and cosmetics used for health care is a big market in India and the world. Various big companies mint billions of money by huge margin by selling medicines and other health care material. Every one in this world in general must have used the curable drugs due to some viral, cold or pain etc. So, how these medicines are regulated? Is it only the money game or the government really cares about the medicines or health care we take?
About India’s Drug Regulation Ecosystem
Usually the patients lack the specialized knowledge required to identify whether drugs are safe, genuine, and efficient or adulterated, spurious and substandard.
The Drug Regulation Ecosystem plays an important role by ensuring that only safe, good quality and efficacious drugs reach the patients.
The Indian Drug Regulatory System originated from the Drugs & Cosmetics Act, 1940. It regulates the import, manufacture, distribution and sale of drugs and cosmetics.
The 1940 act and its corresponding rules allow the Centre and State to regulate different aspects of the drugs ecosystem. The 1940 act also provides for other statutory bodies for various functions
Last year an incident of lethal syrups came to picture manufactured by an Indian company.
These syrups were ‘potentially linked with acute kidney injuries and over 66 deaths among children in Gambia.
The preliminary enquiry from Central Drugs Standard Control Organisation (CDSCO) has revealed that the manufacturer was licensed by the State Drug Controller for the products under reference.
The tentative results on syrups showed presence of Diethylene Glycol (DEG)/ Ethylene Glycol. They are toxic in nature. In India also, at least five cases of DEG poisoning had happened since 1972 including the 2020 incident in Jammu leading to death of 17 children.
What are the challenges in India’s Drug Regulatory Ecosystem?
Unclear Distribution of Powers and Responsibilities between the Centre and the States lack clearly codified distribution of powers and responsibilities. For instance, with Health being a State subject under the 7th schedule of the Constitution, states also exercise substantial drug regulation in addition to the provisions of the Act of 1940.
Unlike other regulators, CDSCO is not a statutory body - leading to relatively lesser independence and autonomy. Also, the State Drug Regulatory Authorities (SDRAs) are statutory bodies but they face issues of lack of uniformity and proper demarcation of responsibilities. E.g. they are often conjoined with the food regulation department.
Indian drug regulation follows a command-and-control architecture where the regulator prescribes standards, distributes licenses, and then undertakes inspection to check for compliance.
While it provides clarity in regulatory standards, it also requires considerable investment in human resources and physical infrastructure to set standards, maintain records, conduct inspections, collect, and test samples, etc. But CDSCO lacks access to resources required to ensure compliance of around 10,500 pharmaceutical manufacturing units of 3,000 drug companies across the country.
The problem is more acute amongst SDRAs, leading to overworked workforce and inefficient administration.
Some CDSCO and SDRAs officials have been caught in the past by CBI for offences like accepting bribes for drug approval.
Recently, draft of ‘The Drugs, Medical Devices and Cosmetics Bill, 2022’ was also shared by the Ministry of Health and Family Welfare. But the ecosystem warrants dedicated, structural and holistic reforms.
What can be done to overcome these challenges?
The safety, quality and efficacy of the medicines is critical in building up faith in India’s pharmaceutical manufacturers as well as the health system and health professionals, domestically as well as globally. So, to ensure people faith, good health and strengthen India’s image as ‘Pharmacy of the World’, the government can build a streamlined Regulation System which clearly demarcates the responsibilities of all the stakeholders and ensures effective coordination wherever needed.
It will help in greater uniformity or harmonized application of drug regulatory standards throughout the country.
Providing Statutory Recognition to CDSCO to ensure regulatory independence and autonomy and building International Co-operation to strengthen regulation and have more manufacturing units adhering to Good Manufacturing Practices (GMP) set by the WHO, are some practices that government can do.
Allocate Sufficient Resources for financial independence, and required physical infrastructure/human resources for effective regulation. E.g. implementing the Mashelkar Committee formula of one drug inspector per 50 manufacturing units and per 200 sales/distribution outlets.
Ensure Transparent Regulatory Decision-making for better compliance, consistency and trust among stakeholders. Public Outreach, both by CDSCO and SDRAs for a proactive public engagement to address information asymmetry and participatory decision-making and using the technology to overcome resource constraints with other benefits such as digital databases, ease of licensing etc.
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