Editorial: Testing time for pharma

Appropriate reforms must be initiated to make the regulatory process more effective for pharma industry

Hyderabad: The latest changes in the pharma export policy are part of a damage control exercise by India whose reputation as a global pharma hub took a severe beating recently following the deaths in Gambia and Uzbekistan linked to Indian-made cough syrups. The new policy makes it mandatory for cough syrup makers to get samples tested and obtain a certificate of analysis from a government-approved laboratory before exporting their products. Many Indian pharma companies have come under scrutiny in recent times for the quality of their drugs, with experts raising concerns over their manufacturing practices and ineffective regulation. The twin tragedies in Gambia and Uzbekistan, resulting in the death of nearly 90 people due to the consumption of adulterated cough syrup, had cast a pall over India’s pharmaceutical industry, which makes a third of the world’s medicines. The World Health Organization (WHO) issued an alert last October linking four Indian-made cough syrups to child deaths in Gambia. In March this year, the manufacturing licence of Noida-based Marion Biotech was cancelled as cough syrups exported by it were linked to 18 child deaths in Uzbekistan. Criminally negligent pharma unit promoters should be prosecuted. The Indian pharmaceuticals industry, ranked third worldwide by volume, must learn lessons from both tragedies and appropriate reforms must be initiated to make the regulatory process more effective. Nearly 3,000 firms operate over 10,000 pharmaceutical factories making generics, over-the-counter medicines, vaccines and ingredients in what is one of the world’s largest drug-making countries.

India’s traditional expertise in making generics has helped make it a formidable low-cost maker of drugs and become a global manufacturing base. Nearly 40% of over-the-counter and generic medicines sold in the United States and a quarter of all medicines dispensed in the UK come from India. The country supplies some two-thirds of antiretroviral drugs globally to fight HIV. Indian drugmakers account for 60% of the world’s vaccines and 20% of generic medicines. And, Africa is an important market as India supplies half of its generic medicine needs. The country exported cough syrups worth $17.6 billion in 2022-23. Despite these achievements, the Indian pharma industry has been clouded by problems of quality and weak regulation. State-run drug testing labs in many States are underfunded, short-staffed and poorly equipped. The quality control crisis has been compounded by charges of lax, inefficient and corruption-ridden drug approval processes that do not follow exacting standards applied in other parts of the world. Zero tolerance for violation of rules is the foundation on which the pharma sector is expected to stand. Drug regulatory authorities at the Central and State levels need to get their act together and work in close coordination. Strict action should be taken against officials who overlook lapses by pharma firms. Unsafe products must be weeded out before it is too late.

---