Editorial 1: The lack of a drug recall law in India
Context
- There is rise of substandard drugs in the India due to lack of regulatory standards and no law to recall drugs.
Drug regulation 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..
- 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.
- 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.
- Under the Drug and Cosmetics Act(DCA), 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.
Challenges in regulation
- Fragmented regulatory structure - Since each state have its own regulators and there are totally 38 drug regulators in India, so if a drug is banned from one state it can be sold in another state.
- Jurisdictional issues - Many regulators has led to inconsistent enforcement of the law and jurisdictional issues.
- No focus on process - The Indian system is still oriented towards end products (medicines sold in the market) rather than processes.
- No transparency - There are no transparency requirements or mandatory disclosures of medicinal requirements in the law.
- Drug regulation being complex - Drug regulation section of the union health ministry find it difficult to regulate since the regulation process is complex.
- Lack of expertise - In the drug relation section of the union health ministry.
- Pharmaceutical industry over protecting public health - The government has greater interest in enabling the growth of the pharmaceutical industry than protecting public health.
- No law on drug recall - Even though government has been mulling for a binding a law on drug recall since 1976, there exists guild lines for drug recall.
Suggestions
- Amend the Drugs and Cosmetics Act: The primary goal of the Drugs and Cosmetics Act is not to respond to substandard drugs retrospectively, but to prevent them altogether. So, the DCA has to be amended to prevent the manufacturing of substandard drugs in the first place.
- Adopt Good Manufacturing Practices: Manufacturers should adopt a strict quality control system. There is a need to follow simple checks and balances, such as testing a raw material before putting it into a drug, buying raw material from a licensed manufacturer, and maintaining clean equipment, etc.
- Coordination and uniformity between various departments: Every state follows different standards to regulate the cases. A mechanism should be built, where regulators should have proper communication links between them. Also, a set of uniform standards should be followed.
- Address the systemic issues in Drug regulation: There is a need to provide adequate training to the staff. Also, the vacancies should be filled immediately so that they are not overburdened.
Way forward
- 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. 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.
Editorial 2: Buddhism, India’s soft power projection tool
Context
- The two-day Global Buddhist Summit 2023 concluded successfully in New Delhi recently with the adoption of the New Delhi Declaration.
Background
- It was organised by the Ministry of Culture in collaboration with the International Buddhist Confederation.
- The summit saw the participation of key figures from the global Buddhist community, including the Dalai Lama.
- It was at this summit that the Prime Minister, Narendra Modi, laid emphasis on the continuing relevance of the Buddha’s teachings in today’s world.
- The summit was a significant opportunity for India to project and connect with the Buddhist population around the world, thereby strengthening the country’s soft power.
India’s efforts so far
- The Indian government has been actively investing in its Buddhist diplomacy efforts, with a focus on promoting tourism through the development of the “Buddhist tourist circuit”.
- By hosting such a high-profile event, the Indian government hopes to demonstrate its commitment to preserving and promoting Buddhist culture and heritage, as well as strengthening ties with the global Buddhist community.
- Against the backdrop of the Russia-Ukraine crisis, Mr. Modi said, “India has not given ‘Yuddha’ to the world but ‘Buddha’.” This resonates with his earlier statement of his telling the Russian President, Vladimir Putin, that ‘this is not the era of war’.
- The Delhi summit’s theme, “Responses to Contemporary Challenges: Philosophy to Praxis”, also highlights India’s attempts to provide an alternative to contested global politics, with morality as the guiding principle
Buddhism and Indian diplomacy
- Ties with East and Southeast Asia: India’s historical and cultural ties with East and Southeast Asia, where Buddhism is widely practiced, have helped to strengthen diplomatic relations with these countries through initiatives such as the Look East Policy and the Act East Policy.
- Relationship with China: Buddhism has been a significant factor in India’s relationship with China. Buddhism originated in India but spread to China and became a major influence on Chinese culture. The annual India-China Buddhist Dialogue and the China-India Yoga College promotes Indian culture and yoga in China.
- Cultural Diplomacy: India has established several Buddhist study centers and universities in different parts of the world to promote Indian culture and Buddhism. India also hosts several international conferences and seminars on Buddhism.
- International Cooperation:. India has been a strong supporter of the United Nations International Day of Vesak, which celebrates the birth, enlightenment, and passing of the Buddha, and has hosted the event several times.
Need for more action
- India recognises the importance of Buddhism as a means of conducting public diplomacy . However, to maintain its edge over China, more action is needed.
- India should continue promoting Buddhism at the highest levels of government. The Indian Council for Cultural Relations (ICCR) could play a significant role in promoting such events within and outside India.
- India should work to strengthen its ties with key Buddhist institutions and leaders around the world. The Delhi summit was a step in the right direction, providing a valuable opportunity for cultural exchange and the sharing of ideas.
- India also needs to utilise the reach of Bollywood in promoting its Buddhist heritage.
- India’s G-20 presidency this year could be used to promote Buddhist diplomacy on a bigger scale through various cultural meetings, especially as Buddhist teachings align with the motto of India’s G-20 presidency, ‘One Earth, One Family, One Future’.
Conclusion
- As Buddha was the first diplomat of peace, his teachings of peace and cooperation in these tough times can become the guiding light of Indian diplomacy on the world stage.