Appropriate reforms must be initiated to make the regulatory process more efficient for the pharmaceutical industry
Posted Date – Thursday, 5/25/23 at 12:15pm
Appropriate reforms must be initiated to make the regulatory process more efficient for the pharmaceutical industry
Hyderabad: The latest change in drug export policy is part of damage control measures in India, whose reputation as a global pharmaceuticals hub has recently been dealt a severe blow following deaths in Gambia and Uzbekistan from cough syrup made in India. The new policy makes it mandatory for manufacturers of cough syrup to test samples and obtain a certificate of analysis from a government-approved laboratory before exporting the product. Many Indian pharmaceutical companies have recently come under scrutiny for the quality of their medicines, with experts raising concerns about their manufacturing practices and poor regulation. The twin tragedies of nearly 90 people dying in Gambia and Uzbekistan after consuming adulterated cough syrup have cast a shadow over India’s pharmaceutical industry, which produces a third of the world’s medicines. The World Health Organization (WHO) issued an alert last October linking four types of cough syrup made in India to child deaths in Gambia. In March, Noida-based Marion Biotech’s manufacturing license was canceled after the company’s export of cough syrup was linked to the deaths of 18 children in Uzbekistan. Pharmaceutical unit promoters guilty of criminal negligence should be prosecuted. The Indian pharmaceutical industry, which ranks third in the world, must learn from these two tragedies and appropriate reforms must be initiated to make the regulatory process more effective. In one of the world’s largest pharmaceutical nations, nearly 3,000 companies operate more than 10,000 pharmaceutical plants producing generic drugs, over-the-counter medicines, vaccines and ingredients.
India’s traditional expertise in making generic drugs has made it a strong low-cost drug maker and a global manufacturing base. Nearly 40% of over-the-counter and generic medicines sold in the US and a quarter of all medicines sold in the UK come from India. The country supplies about two-thirds of the world’s antiretroviral drugs to fight HIV. Indian drugmakers produce 60% of the world’s vaccines and 20% of generic drugs. Moreover, Africa is an important market as India supplies half of its generic drug needs. The country exported cough syrup worth $17.6 billion in 2022-23. Despite these achievements, the Indian pharmaceutical industry remains clouded by quality issues and poor regulation. State-run drug testing laboratories in many states are underfunded, understaffed and poorly equipped. The quality control crisis has been compounded by allegations of lax, inefficient and rampant corruption in the drug approval process, which does not follow the strict standards applicable in other parts of the world. Zero tolerance for breaking the rules is the foundation upon which the pharmaceutical industry stands. The central and national drug regulatory departments should form a joint force and cooperate closely. Strict action should be taken against officials who ignore drug company missteps. Unsafe products must be eliminated before it is too late.
