Danger of Poorly Manufactured Drugs
Context:
The recent tragic deaths of five young mothers in Ballari district, Karnataka, allegedly due to contaminated drugs manufactured by a pharmaceutical company in West Bengal, have brought the spotlight back on the systemic issues plaguing drug regulation in India.
Challenges in Drug Regulation
- India’s regulatory framework, governed by the Drugs and Cosmetics Act, 1940, allows pharmaceutical companies licensed and inspected in one State to sell their products across the country.
- However, the decentralised nature of the law creates enforcement gaps.
- States are responsible for licensing and inspecting manufacturing units within their jurisdiction, leaving them with little control over the quality of drugs manufactured elsewhere.
- This regulatory limitation is evident in Karnataka, where out of 894 drug samples tested over three years, 601 non-standard quality (NSQ) samples originated from manufacturers outside the State.
- While the Karnataka Drugs Control Department can initiate criminal prosecutions against such companies, these cases often take years to resolve, during which manufacturers continue to sell their products freely.
- Only drug inspectors from the home State of the pharmaceutical company have the authority to cancel or suspend manufacturing licences, leaving other States virtually powerless in ensuring quality control.
Promoting Information Sharing
- A simple yet effective solution to improve drug quality is to promote better information sharing between State drug control departments and public procurement agencies.
- Currently, there is no mechanism for drug inspectors in Karnataka to access information about the track records of pharmaceutical manufacturers from other States.
- Creating a centralised database of drug testing results from all State and central laboratories would allow inspectors to track instances where a company’s drugs have failed quality tests.
- Such a tool would enable a risk-based approach to enforcement and procurement decisions.
- Similarly, centralising inspection reports and licensing data for all manufacturers would empower procurement agencies like the Karnataka State Medical Supplies Corporation Ltd. (KSMSCL) to verify the credentials of companies before purchasing drugs, reducing the risk of procuring substandard products.
Blacklisting and Accountability
- Another essential measure is the establishment of a national register by the Union Ministry of Health to record pharmaceutical manufacturers blacklisted for supplying NSQ drugs.
- A centralised register would help eliminate unreliable manufacturers and improve the quality of drugs available in public healthcare facilities.
- Currently, most procurement tenders require companies to disclose if they have been blacklisted, but there is no independent mechanism for verifying these claims.
Regulatory Framework
Drugs and Cosmetics Act, 1940: This act regulates the manufacture, sale, and distribution of drugs and cosmetics in India. The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, is the central authority responsible for overseeing drug regulation.
Narcotic Drugs and Psychotropic Substances Act, 1985: This act addresses the control and regulation of narcotic drugs and psychotropic substances to prevent abuse and illicit trafficking. It establishes the Narcotics Control Bureau (NCB) for enforcement against drug trafficking.
State Drug Regulatory Authorities (SDRAs): Each state has its own regulatory authority that manages: Licensing of manufacturing units within the state and Quality control inspections at local pharmacies and manufacturers.
Empowering States with Legal Authority
- Reforms should also empower individual States to act against out-of-State manufacturers supplying NSQ drugs.
- State drug controllers should have the authority to bar such manufacturers from selling drugs within their jurisdiction until they rectify the issues that led to the production of substandard drugs.
- However, amending the Drugs and Cosmetics Act, 1940, to grant such powers requires central legislative action.
- States like Karnataka are willing to support such reforms, but the initiative must come from the Union Health Ministry.
- The recent incidents serve as a stark reminder of the need for systemic changes in India’s drug regulatory framework. By fostering greater transparency, accountability, and collaboration, India can ensure the availability of safe and effective medicines for all.
