India, renowned as the global largest manufacturer of generic medicines, plays a crucial role in global healthcare. This vibrant industry provides affordable medication for the world’s poorer populations and currently commands a market value of USD 50 billion. By exporting pharmaceuticals to over 200+ countries, India’s pharmaceutical industry is expected to reach USD 65 billion by 2024 and USD 130 billion by 2030. However, it has recently faced significant challenges, particularly pertaining to product quality and safety.
Recent Quality Control Failures: A Closer Look
In recent years, several incidents have cast a spotlight on the Indian pharmaceutical sector’s production quality. For instance, in January 2020, twelve children in Jammu died after consuming a contaminated medicine found to contain diethylene glycol which led to kidney poisoning. Similarly, in March 2021, an inspection of Nycup syrup revealed lower levels of active ingredients.
Furthermore, the World Health Organization (WHO) issued a medical product alert in October 2022 concerning acute kidney injury in children and 66 deaths in Gambia linked to four products from India-based Maiden Pharmaceuticals. In December 2022, the Central Drugs Standard Control Organisation (CDSCO) began investigating the death of another 18 children in Uzbekistan due to an Indian cough syrup. Recently, US health agencies raised concerns on a drug-resistant bacterial strain linked to Indian-made eye drops.
Notably, the latest regulatory checks in India revealed that 48 drugs failed to meet quality standards, including 3% of drugs used for common conditions like hypertension, allergies, and bacterial infections.
Challenges Faced by India’s Pharma Sector
Issues facing this thriving industry include Intellectual Property Rights (IPR) lawsuits, balancing pricing and affordability, and healthcare infrastructure and access. Indian pharmaceutical companies have encountered several allegations of violating IPR laws, leading to costly legal disputes with multinational pharmaceutical companies. These legal battles coupled with the challenge to balance medicine affordability with firm profitability pose significant difficulties for the industry.
The country also grapples with a healthcare infrastructure that fails to avail medicines to a considerable segment of the population due to inadequate infrastructure, uneven facilities distribution, and low health insurance coverage.
Government Initiatives Directed Towards the Pharmaceutical Industry
To address these challenges, the Indian government has launched initiatives like the Production Linked Incentive (PLI) Scheme, the Promotion of Bulk Drug Parks Scheme, and the Strengthening Pharmaceuticals Industry Scheme.
Suggested Reforms for India’s Pharma Sector
In order to reform the sector, comprehensive changes are necessary. Firstly, legislative amendments and a centralized drugs database can enhance regulation throughout all manufacturers. Secondly, encouraging more pharmaceutical manufacturing units to acquire WHO’s Good Manufacturing Practice certification can uplift industry-wide quality standards. Lastly, integrating transparency, credibility, and accountability into the drug regulatory regime is crucial.
Emphasis on Sustainable Manufacturing Practices
Lastly, ushering in sustainability via green chemistry, waste reduction, and energy efficiency can improve the sector’s environmental footprint while reducing costs. Adopting environmentally friendly practices can build a positive brand image, attract conscious consumers, and contribute to a sustainable future.
