In the wake of recent reports of India-made cough syrups causing the deaths of dozens of children in Uzbekistan and Gambia, the Indian government has announced new measures to improve the quality and safety of its drug manufacturing industry. India, which is one of the world’s largest producers and exporters of generic medicines, has faced criticism for its lax regulation and oversight of its pharmaceutical sector.
New Regulations
According to a press release issued by the Ministry of Health and Family Welfare on January 5, 2024, the government has decided to implement several reforms to ensure that Indian drugs meet the highest standards of quality and efficacy. Some of the key reforms include:
- Increasing the frequency and intensity of inspections of drug manufacturing units, both domestic and foreign, by the Central Drugs Standard Control Organization (CDSCO), the country’s drug regulator.
- Strengthening the testing and monitoring of drug samples by accredited laboratories across the country, and imposing strict penalties for non-compliance and falsification of data.
- Enhancing the capacity and skills of drug inspectors and analysts through training and certification programs, and providing them with modern equipment and technology.
- Establishing a national database of drug manufacturers, products, batches, test results, recalls, adverse reactions, and complaints, and making it accessible to the public and other stakeholders.
- Harmonizing the Indian drug standards with the international norms and guidelines issued by the World Health Organization (WHO) and other agencies.
The ministry said that these reforms will be implemented in a phased manner over the next two years, and that it will seek the cooperation and support of the state governments, industry associations, civil society groups, and consumers in this endeavor.
Industry Response
The Indian Pharmaceutical Alliance (IPA), a trade body representing some of the major drug makers in India, welcomed the government’s initiative and expressed its commitment to comply with the new regulations. In a statement, IPA president Dr. Rajesh Jain said that “the IPA fully supports the government’s efforts to enhance the quality and safety of Indian drugs, which are essential for ensuring public health and trust. We believe that these reforms will not only benefit the Indian consumers, but also boost our exports and reputation in the global market.”
However, some smaller and medium-sized drug manufacturers expressed their concerns over the possible impact of the new regulations on their business and competitiveness. They said that they may face difficulties in meeting the increased costs and requirements of testing, inspection, and documentation, and that they may lose out to foreign competitors who may have lower standards or more favorable trade agreements. They urged the government to provide them with adequate financial and technical assistance to help them adapt to the new norms.
Public Health Implications
The new regulations are expected to have positive implications for public health, both in India and abroad. According to a study published in The Lancet in 2023, about 3% of drugs routinely taken by Indians for common ailments are substandard, meaning that they do not contain the correct amount or quality of active ingredients. This can lead to reduced effectiveness, increased resistance, adverse effects, or even death. Substandard drugs also pose a threat to global health security, as they can contribute to the spread of infectious diseases such as tuberculosis, malaria, HIV/AIDS, etc.
By improving the quality and safety of its drugs, India can prevent such harms and improve its health outcomes. Moreover, it can also enhance its credibility and reputation as a reliable supplier of affordable medicines to many developing countries that depend on Indian generics for their health needs. According to data from Pharmexcil, India’s drugs and pharmaceuticals exports stood at Rs. 2,08,231 crore (US$ 25.3 billion) for FY23, accounting for 5.92% of India’s global exports. India is also a major source of over-the-counter and generic medicines for developed countries such as the US and UK, where it provides nearly half and a quarter of all prescriptions dispensed respectively. India also supplies some two-thirds of anti-retroviral drugs globally to fight HIV. As Prime Minister Narendra Modi has said, India is proud to be the “pharmacy of the world”, but it also has a responsibility to ensure that its drugs are safe and effective for all.