The Indian pharmaceutical business exemplifies the paradoxical nature of this republic. It requires no introduction after its global performance during the pandemic years. Before delving deeper into the industry’s ups and downs, it will be fascinating to examine India’s pharmaceutical prowess.
As per The New Indian Express, in 2021, the industry was predicted to be worth $42 billion. With a 20% share of total global pharmaceutical exports, India is the world’s largest provider of generic medicines by volume. It is also the world’s largest vaccine supplier by volume, accounting for more than fifty percent of all vaccines manufactured worldwide.
Indian exports fulfill the criteria and needs of the highly regulated markets of the United States, United Kingdom, European Union, and Canada due to the country’s mega-production capability and big number of skilled workers.
According to the department of pharmaceuticals, Union ministry of chemicals and fertilizers, the domestic pharmaceutical market had a turnover of Rs 129,015 crore (US$18.12 billion) in 2018, an increase of 9.4% year-over-year, with export revenue estimated at US$17.28 billion in FY18 and US$19.14 billion in FY19. Despite such a track record, some of the most foolish, if not deadly, actions of the sector defy explanation.
Last week, a Chennai-based pharmaceutical company suspended production of a line of eye drops from the US market after the country’s health protection agency reported that they may be contaminated with a drug-resistant bacteria linked to reports of permanent vision loss and one death from a blood infection.
A preliminary report by the Central Drugs Standard Control Organisation (CDSCO) stated that the decision was made following a joint inspection with state officials.
The US Centers for Disease Control and Prevention (CDC) published a health notice to doctors last week, recommending them not to sell or prescribe EzriCare Artificial Tears manufactured by Global Pharma Healthcare Pvt Ltd. Authorities said that infections with a drug-resistant bacteria were the cause of some cases of irreversible blindness.
This is certainly not an exception. In October of last year, the World Health Organization (WHO) issued a global notice on four cough syrups, warning that they may have contributed to the deaths of 66 children in The Gambia, north Africa. According to the report, the syrups have been “possibly connected to acute kidney damage and 66 deaths among youngsters.”
The items were made by an Indian company, Maiden Pharmaceuticals, which had failed to give safety assurances, the WHO stated as a precaution. Late in July, medical authorities in The Gambia, a renowned tourist destination, observed an upsurge in instances of acute renal damage among children under the age of five. This prompted the WHO to intervene. The government of the Gambia has subsequently banned the use of all paracetamol syrups and recommended its citizens to take pills instead.
The WHO stated that India’s CDSCO indicated that the firm may have exclusively provided The Gambia with tainted drugs. The Indian authorities shut the Maiden Pharmaceuticals plant that produced cough and cold syrups contaminated with dangerous chemicals, according to the World Health Organization.
A senior WHO official acknowledged that Indian government health officials had shut down the facility after sharing data indicating that samples of four syrup formulations made by the company and examined by the global health agency contained human-toxic diethylene glycol and ethylene glycol.
This was certainly not Maiden Pharmaceuticals’ first offense. They have been disciplined for producing poor medications. According to data from the Xtended Licensing and Laboratory Node, a government database, the company has been cited for defective tablets at least five times in Kerala in the past few years. In 2011, it was placed on a blacklist by the government of Bihar.
In 2014, the Vietnamese government blacklisted Maiden, along with 66 other Indian firms, for violating Quality Control Regulations and Drug Regulations. Both the central and state governments of India need to get their act together. Due to their interest in the licensing revenue that the sector provides, the majority of states turn a blind eye to best practices, allowing such violations to persist.
The greater concern is lack of regulatory clearance openness. Indian law mandates that every manufacturing plant be inspected annually for compliance with good manufacturing practice (GMP). However, there is one notable exception that is unique to India: inspection results are rarely made public.
In the preceding decade, over 7,500 medical samples failed quality testing in the states of Gujarat, Kerala, and Maharashtra, according to test results. Each failed sample represents hundreds of thousands of tablets, syrups, and injectables that patients across the country have eaten. These include contamination by glass particles and bacterial endotoxins, among other problems.
In contrast, it is interesting to note that the all-powerful United States Food and Drug Administration (USFDA) makes its inspection records accessible to the public online! Industry sources assert that Indian pharmaceutical businesses sell low-quality medications in Africa, and senior authorities who were interviewed following the fatalities in Gambia confirmed this!
According to a study conducted by researchers from the University of Ottawa and the University of Maryland, Indian producers are likely to offer low-quality goods in Africa due to the continent’s lax laws. What else could it be besides an instance of blatant apartheid?
Clearly, India must strengthen its policies and clearance procedure if it wishes to become the world’s pharmacy. That would be the icing on the cake for Indian pharmaceuticals.