| PYQ Relevance: Q) How is the government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies? (UPSC CSE 2019) |
Mentor’s Comment: UPSC Mains has always focused on Drug regulation (2013) and Patent Issues in India (2018).
India ranks as the third largest producer of pharmaceuticals in terms of volume and fourteenth largest in terms of value globally.
Today’s editorial highlights the critical issue of drug quality and safety, particularly concerning pharmaceuticals produced in countries with regulatory frameworks. This content can be used in your Mains answer writing while discussing the implications for public health, especially in low- and middle-income families, where substandard medications can lead to severe health crises.
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Let’s learn!
Why in the News?
The Central Drugs Standard Control Organisation (CDSCO) has flagged over 50 common medications as “Not of Standard Quality” (NSQ), including widely used drugs for conditions such as diabetes, hypertension, and acid reflux.
- Notable examples include Telmisartan, Glimepiride, and Paracetamol.
| What is India’s Drugs and Cosmetics Act, 1940? • It regulates the import, manufacture, and sale or distribution of drugs and cosmetics through licenses and permits. It has to ensure that the drugs and cosmetics marketed in India are reliable, efficient, and in compliance with national standards. • The associated Drugs and Cosmetics Rules, 1945, which were formulated in association with the 1940 Act, provide provisions for classifying medications into schedules and instructions for the storage, sale, presentation, and prescription of each schedule. Other provisions laid under this Act include: • The Act oversees medication imports into India as well as prohibits the production of inferior or counterfeit pharmaceuticals in the country. • To form a Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committees (DCC) for allopathic and allied drugs, as well as cosmetics. Salient Features of the Act: • The maximum penalty is life imprisonment and a fine of Rs. 10 lakhs or three times the confiscated goods’ value, whichever is greater. • Other gazette officers and officers from the Central Drug Controller’s Office (CDSCO) are authorized to initiate prosecution under the Act; some offenses are cognizable and non-bailable. • Specialized courts for the trial of offenses covered by the Act and provision for the aggregation of minor offenses. |
What are the recent challenges?
1) Regulatory Challenge: Since each state is responsible for licensing and inspecting pharmaceutical manufacturing units located within its territory, it means that there is little that States can do to stop poorly manufactured drugs.
- The only tool available to prosecute pharmaceutical companies for Not of Standard Quality (NSQ) drugs is lengthy criminal prosecution.
- During trials, companies can continue manufacturing and selling drugs in Karnataka.
2) Verification Issues: Current tender requirements ask companies to disclose blacklisting but lack independent verification methods for procurement officers
| CASE STUDY: Tainted cough syrups from India resulted in the deaths of at least 89 children in Gambia and Uzbekistan. Such incidents underline the urgent need for stringent quality control measures. India and China, are significant players in global drug manufacturing, where they supply a substantial portion of Active Pharmaceutical Ingredients (APIs) used in generic drugs worldwide. However, the regulatory oversight in these regions is often inadequate. For instance, India’s pharmaceutical sector, which accounts for over 20% of the world’s generic drugs, has faced scrutiny following incidents involving contaminated products that have resulted in fatalities abroad. |
What are the Socio-economic impacts on the Society?
- Social Implications: The WHO estimates that around 10% of medical products in low- and middle-income countries are either substandard or falsified. These medications can lead to treatment failures, increased morbidity, and even mortality.
- Economic Implications: The economic burden of substandard medications is profound. Families may spend their limited resources on ineffective treatments, leading to financial strain and loss of trust in healthcare systems. This erosion of confidence can have long-term repercussions on public health initiatives.
| How can a centralized database help with drug quality assurance? A Centralized Drug database will enable agencies like KSMSCL to verify pharmaceutical companies’ credentials before purchasing drugs, and prevent issues like the recent scandal in Maharashtra that involved spurious antibiotics. This will eventually help procurement officers to assess the quality of inspections across states and prioritize manufacturers with rigorous inspection records. |
Solutions and Recommendations (Way Forward)
- Promoting Information Sharing: Encourage greater collaboration between state drug control departments and public procurement agencies.
- Establish a centralized database for drug testing results from all central and state laboratories.
- Benefits of Centralized Data: A centralized database would allow drug inspectors to track the failure rates of pharmaceutical companies’ products across the country.
- This would enable a risk-based approach in enforcement and procurement decisions, enhancing overall drug quality.
- Recommendations: The Union Ministry of Health recommended creating a central register of pharmaceutical manufacturers blacklisted for supplying Not of Standard Quality (NSQ) drugs.
- It aims to enhance drug quality and eliminate unreliable suppliers from the market, thereby improving the safety of drugs available in public hospitals.
