It is not enough to be the volume leader; India must increase the value of volume leadership.
UPDATE – 12:25 AM, SAT – 1/14/23
It is not enough to be the volume leader; India must increase the value of volume leadership.
Hyderabad: Most important for India’s export-oriented pharmaceutical industry is global awareness. Recent tragedies in Gambia and Uzbekistan, in which the deaths of nearly 90 children were linked to adulterated cough syrup produced by Indian pharmaceutical companies, have severely damaged the country’s reputation as a global pharmaceutical hub. Against this backdrop, the cancellation of the manufacturing license of Noida-based Marion Biotech linked to the deaths in Uzbekistan is a welcome move that should lead to an overhaul of the drug regulatory and quality control system. The license was revoked after the World Health Organization notified the company that two cough syrups it produced should not be used in children after they were found to contain toxic ethylene glycol and were linked to the deaths of 19 children in Uzbekistan. The two tragedies are a wake-up call for policymakers who need to reassess India’s drug manufacturing and regulatory environment. Such an approach would be beneficial both nationally and globally, given the burgeoning and huge growth potential of India’s pharmaceutical export market. India may be proud of winning the title of “pharmacy of the world”, but with that comes the responsibility to ensure products meet the strictest standards, which could make the difference between life and death. At present, there are many shortcomings in the drug regulatory mechanism. The existence of multiple regulatory agencies under different state governments affects accountability. Now is the time to revise the Drugs and Cosmetics Act.
The Ministry of Health and Family Welfare released the draft Medicines, Medical Devices and Cosmetics Bill 2022 for public comments last July. Once enacted, the draft bill will replace the existing bill. The bill raised hopes of stricter regulation to ensure drug quality. India needs to have a strong regulatory structure and strong enforcement agencies so that both domestic and exported medicines are of high quality. As the pharmaceutical industry seeks to expand its operations, the key to success is continuous investment in improving manufacturing standards. India must maintain its image of providing quality and reliable medicines to the world. It is not enough to be the volume leader; India must increase the value of volume leadership. The world’s third largest drug producer, India’s pharmaceutical industry is worth $42 billion. During 2020-21, the country exported pharmaceutical products worth USD 24.6 billion. The top five destinations for shipments of pharmaceuticals from India are the US, UK, South Africa, Russia and Nigeria. About 40% of generic drugs sold in the US and a quarter of all medicines sold in the UK come from India. With its price competitiveness and good quality, Indian drugmakers have achieved global success, accounting for 60% of the world’s vaccines and 20% of generic drugs.
