India is the world's largest supplier of generic drugs, and its fast-growing US$42 billion pharmaceutical industry plays a significant role in providing affordable healthcare to millions of people worldwide. 

In the UK alone, four out of five drugs used by the NHS are generic medicines – and around one-third of them come from India. India supplies 40% of US generics and 45% of Africa’s. The country also supplies more than half the world’s vaccines. In addition, about 50% of the pharmaceutical ingredients of all generic medicines are produced in the country, meaning manufacturers around the world rely on raw materials from India.

However, the sector has been plagued by concerns over the quality and safety of drugs produced in the country. One of the key issues is the lack of a robust batch release regulatory testing system, which has led to manufacturers failing to maintain quality control over their fragmented supply chains. The situation is exacerbated by a shortage of inspectors in a sector in which some 3,000 companies run 10,500 generic manufacturing plants.

Quality Control issues in the Indian generic drugs sector
Several cases in recent years have highlighted concerns over the quality and safety of drugs produced in India and the need for a more robust regulatory testing system. 

In 2018, the Indian government suspended the license of one of the country's largest drug manufacturers, Wockhardt, due to several violations of good manufacturing practices. The company was found to have failed to maintain quality control over its supply chain, resulting in the production and distribution of substandard drugs. In another case, Ranbaxy Laboratories, India's largest pharmaceutical company, was found guilty of several violations, including falsifying data, leading to the recall of several drugs in the US market and a US$500 million fine.

More recently, India-made eyedrops have been linked in the US to a rare, drug-resistant bacteria causing infections, blindness and one death in what has been termed a “superbug” outbreak. India-made cough syrup has also been under the spotlight from the WHO over the deaths of 90 children in Gambia and Uzbekistan from kidney failure. In this case, tests found that the syrups contained toxic industrial grade glycol rather than the safe but costlier pharmaceutical-grade glycerine.

Challenges facing regulators in India
A lack of adequate testing facilities to ensure compliance with international standards is just one factor creating difficulties for regulators in keeping up with the growing industry.

One of the main reasons regulators in India are unable to deal with quality control issues is the sheer volume of drugs produced in the country. Thousands of manufacturers produce millions of drugs, often operating in remote or inaccessible areas. This makes it especially challenging for regulators to monitor operations effectively to ensure that each batch is adequately tested before being released into the market. And with a lack of centralised information sharing, drugs that fail quality tests in one state can continue to be sold in another.

The system is further challenged by a lack of adequate funding and resources at state and federal levels, and this inevitably leads to gaps in the regulatory testing process. Taking advantage of this systemic lack of transparency and accountability many manufacturers, in the rush to get their products to market faster, have become proficient in exploiting loopholes and identifying “short cuts” to circumvent regulatory oversight.

In a system where firms are able to get officials to look the other way, it comes as no surprise that the FDA inspections of manufacturing facilities in India regularly uncover falsified test data, adulteration, impurities, substandard quality control, faulty equipment and hygiene issues.

And it’s not just the US, UK and EU that are affected. India exports high volumes of generics to Africa, Southeast Asia and Latin America, markets that are unable to check safety on their own and that rely on India to ensure the drugs are safe.

Using batch release testing facilities in the UK
Given the concerns over the quality and safety of drugs produced in India, one possible solution is to use batch release testing facilities in the UK. These facilities are equipped with state-of-the-art testing equipment and are staffed by highly trained professionals who are experts in pharmaceutical testing.

Using batch release testing facilities in the UK would provide an additional layer of quality control and help to ensure that drugs originating from India meet international standards. 

The UK’s well-established regulatory system and batch release testing facilities are among the best in the world. By outsourcing testing to these facilities, manufacturers in India could benefit from the expertise and resources of the UK regulatory system, ensure that their drugs are safe and effective, and help to rebuild the reputation of the Indian pharmaceutical industry as a reliable supplier of generic drugs.
 

Declaration of Interest:  Hoeford Research conducts regulatory in vivo toxicology batch release studies for clients in the global pharmaceutical sector.