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Hilal English

Indian Pharmaceutical Industry: A Dangerous Savior

October 2023

This article delves into the grave concerns surrounding the Indian pharma sector, which has resulted in numerous casualties and severe health hazards to its consumers, underlining the urgency for stringent regulatory measures, reassessment of its practices, and a mandatory global crackdown.

The Indian pharmaceutical industry has witnessed a remarkable surge in growth, becoming a crucial player in meeting global healthcare demands. Presently, it produces 20 percent of the world's generic drugs and 50 percent of global vaccines. India claims to be the mantle of the "Pharmacy of the World." As per the Indian government's official statistics, the pharma industry in India has achieved exponential growth, from zero to 13 percent, and is expected to grow to USD 130 billion by 2030. 
To the contrary, the World Health Organization (WHO) and the United States Food and Drug Administration (FDA) have issued several warnings and product alerts to Indian manufactured substandard medicines after discovering an overwhelming number of criminal complaints; illegal rebranding, export of counterfeit lifesaving drugs, and adulterated medicines with life-threatening levels of toxins. 
This article delves into the grave concerns surrounding the Indian pharma sector, which has resulted in numerous casualties and severe health hazards to its consumers, underlining the urgency for stringent regulatory measures, reassessment of its practices, and a mandatory global crackdown.
Ranbaxy Laboratories Scandal
One of the most notorious scandals in the Indian pharma industry involved Ranbaxy Laboratories, leading pharmaceutical companies until 2014. In 2004, the FDA and European drug regulators found adulteration of drugs at several of its facilities in India and blocked imports of medicines from Ranbaxy. 

In October 2016, two Indian pharmaceutical companies were charged under the Indian Drugs and Cosmetics Act for exporting counterfeit diabetes drugs.

The violations included data manipulation, inadequate testing procedures, and false statements made to the FDA. Ranbaxy had to pay hefty fines and faced legal consequences, tarnishing its reputation and casting a shadow over the industry's overall credibility. Ironically, the Indian government responded not with regulatory reform but trumpeted conspiracy theories and “vested interests” working against India.
Notably, in 2008, the U.S. blocked Ranbaxy imports from India for the third time.1 Eventually, in 2013, Ranbaxy Laboratories Ltd. pleaded guilty to U.S. federal criminal charges and agreed to pay USD 500 million for selling adulterated generic drugs, fabricating data, and committing fraud.2 Hence, such repeated offenses committed by Ranbaxy Laboratories resulted in its ban by FDA in February 2014.
Corruption in Central Drugs Standard Control Organization
The Central Drugs Standard Control Organization (CDSCO) is the primary regulatory body for medical devices in India and is equivalent to U.S. FDA. The agency is responsible for ensuring the safety, quality, and efficacy standards of Indian medical devices. In 2012, the Indian Ministry of Health and Family Welfare scrutinized the performance of CDSCO and presented a report before the parliament. This report states that CDSCO was found guilty of colluding with pharmaceutical firms by issuing them illegal licenses for their under-tested and poorly manufactured products. The report also found nexus between drug companies and CDSCO experts. The committee also described CDSCO as an understaffed organization with insufficient resources to carry out its duties.3
Export of Counterfeit Diabetes Drugs
In October 2016, two Indian pharmaceutical companies were charged under the Indian Drugs and Cosmetics Act for exporting counterfeit diabetes drugs.4 Wanbury Ltd, a Mumbai-based Active Pharmaceutical Ingredients (API) manufacturing company, was caught by the Maharashtra Food and Drug Administration for illegally exporting metformin hydrochloride, a diabetic drug, to Mexico, Brazil, Bangladesh, and Pakistan. After inspection, it was revealed that Wanbury had to export orders of 650 metric tons per month, but could manufacture only 300 metric tons. Therefore, to overcome the drug shortage, Wanbury outsourced the manufacturing of diabetes medicine to an illegal company named Pharmaceutical Products of India Ltd (PPIL). The Wanbury then rebranded and exported the drugs it received from PPIL without testing their authenticity and quality, thereby risking the lives of millions across the globe. The illegal activity had been going on for several years. 

After identifying Made in India toxic medicines found in Lebanon and Yemen, the WHO issued a medical product alert warning the consumer, “Please DO NOT use them”

Fake COVID Vaccination Drive 
Indian pharmaceutical malpractices did not stop during the deadly COVID-19 pandemic when every country was fighting against an unseen enemy as one force. The World Health Organization flagged the danger of a fake COVID-19 vaccination drive in India. An important example is Kolkata, where Mimi Chakraborty, a member of parliament, was administered fake versions of Covishield, an Indian version of the AstraZeneca vaccine, and 500 people from the general public.5
A Fifty-Year Track Record of Tainted Medicines 
In their 2022 book titled, Truth Pill, public health activist Dinesh S. Thakur and lawyer Prashant Reddy shed light on a myriad of criminal complaints against the Indian pharmaceutical industry, exposing concerning issues such as the lack of regulatory accountability and non-compliance with scientific methodology. The book underscores the grave implications for consumers of essential lifesaving medicines manufactured in India. Furthermore, the book delves into the alarming revelation of drug contamination with DEG (diethylene glycol) and EG (Ethylene Glycol) chemicals commonly used in polymer production and antifreeze, ubiquitous in Indian manufactured medicines as agents of death since 1972. 
The authors provide compelling evidence by citing five significant DEG poisoning cases that have occurred over the years, drawing attention to the severity of the issue.
The first was reported in 1972 in Madras, now called Chennai, which resulted in the deaths of 15 children. The second case was reported in 1986, killing 14 patients in Mumbai after they consumed Glycerin that had been adulterated with DEG. Bihar was the third region where 11 patients lost their lives in 1988. In the same year, 33 children were killed in Gurgaon, a district neighboring Delhi. Lastly, 11 poor children of Indian Illegally Occupied Jammu and Kashmir (IIOJK) lost the battle of their lives in 2019.6
Recently in February 2020, the deaths of 17 children hailing from IIOJK were brought to the world's attention. Like the previous examples, these children, too, lost their lives due to the contaminated cough syrup made by an Indian company called Digital Vision, which reiterated the long history of criminal complaints against Indian pharmaceutical companies. 
International Cases Linked Criminal Complaints of Made-in-India Medicines
Deaths in Gambia. In October 2022, an Indian-based company named Maiden Pharmaceuticals made cough syrup that caused acute kidney injuries and the deaths of 69 children in Gambia.7 A medical product alert issued by the WHO stated that excessive levels of DEG and EG had been found in the four products produced that were sold to the Gambia by India’s Maiden Pharmaceuticals.8

The landscape of India's pharmaceutical industry stands tainted by corruption and marred by scandalous practices that have resulted in the loss of numerous lives, abnormalities, and organ failure to consumers of Indian manufactured medicines, both in India and globally.

It is worth mentioning that Reuters, in a worrisome revelation, exposed Maiden Pharmaceuticals' collusion to cover its criminal act through corruption. As per Reuter's June 2023 report, Maiden Pharmaceuticals, linked to the massacre of 96 children in Gambia, bribed USD 605,419 to a pharmaceutical regulator for switching samples before being tested by an Indian Government laboratory inquiry.9 
Deaths in Uzbekistan. On December 23, a medicinal syrup manufactured by Indian drug manufacturer Marion Biotech Pvt. Ltd. was also linked to the deaths of 18 children in Samarkand as the syrup contained toxic levels of DEG. Uzbekistan’s Ministry of Health stated that 18 out of 21 children who took the Doc-1 Max syrup while suffering from an acute respiratory disease died after consuming it.10
Contaminated Cancer Drugs in Lebanon and Yemen. On December 27, 2022, the WHO warned that contaminated batches of Indian-manufactured cancer medicines containing life-threatening levels of toxic bacteria were circulating in Lebanon and Yemen. After identifying Made in India toxic medicines found in Lebanon and Yemen, the WHO issued a medical product alert warning the consumer, “Please DO NOT use them.”11
Ingress of Misbranded/Illegal Pharma Companies. As per the Telegraph, in October and November 2022, over five percent of the 2,767 drugs and medical devices tested by the Indian government's regulator were found to be counterfeit, substandard, adulterated, or misbranded.  Moreover, over 80 Indian drug manufacturers who failed quality testing exported their medicines abroad, including two firms to the United Kingdom.
Liberia and Nigeria. On June 14, 2023, Bloomberg revealed that health officials from Liberia and Nigeria confirmed that 250 cartons of children's paracetamol syrup manufactured in India were seized due to toxic DEG and EG.13
Marshall Islands and Micronesia. On April 25, 2023, the WHO issued a Medical Product Alert after identifying Indian-manufactured contaminated syrup found in the WHO region of the Western Pacific, Marshall Islands, and Micronesia. As per the WHO statement, the analysis of Australian-based medicines quality control laboratories, the Therapeutic Goods Administration (TGA) “unacceptable amounts” of  DEG and EG in Indian manufactured cough syrups.14
Made-in-India Contaminated Eye Drops Blinded and Killed Americans. In May 2022, the Indian manufacturer of eye drops, Global Pharma, killed at least three U.S. citizens and blinded many patients.15  The FDA published a report after an 11-day inspection of  Global Pharma's plant in Chennai in 2023.16 The report observed several violations related to sterilization and hygiene and compromised safety norms in the facility in India.
In conclusion, the landscape of India's pharmaceutical industry stands tainted by corruption and marred by scandalous practices that have resulted in the loss of numerous lives, abnormalities, and organ failure to consumers of Indian manufactured medicines, both in India and globally. The gravity of the situation demands urgent global scrutiny and collaborative action. The proliferation of immoral and unlawful malpractices within the industry has brought to light the need for comprehensive regulatory reforms and stricter enforcement of ethical standards. The lack of legal power and inability to conduct surprise inspections or issue subpoenas hampers effective policing, further exacerbating the issue. The devastating impact of unscrupulous practices within India's pharmaceutical sector cannot be understated. The global community must join hands in urging stringent measures to hold those responsible for endangering lives through substandard medications.

E-mail: [email protected]

1.      Katie Thomas, U.S. Bans Import of Generic Drugs From Indian Plant, The NYT, September 16, 2013. https://www.nytimes.com/2013/09/17/business/us-bans-import-of-ranbaxy-drug-made-in-india.html.
2.      Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, cGMP Violations and False Statements to the FDA, May 13, 2013 https://www.justice.gov/opa/pr/generic-drug-manufacturer-ranbaxy-pleads-guilty-and-agrees-pay-500-million-resolve-false.
3.      Gayathri Vaidyanathan, Failings exposed at India’s drug regulator, May 18,2012 https://www.nature.com/articles/nature.2012.10668.
4.      Katrina Megget, October 12, 2016, India pharma firms caught for exporting counterfeit drugs, https://www.securingindustry.com/pharmaceuticals/india-pharma-firms-caught-for-exporting-counterfeit-drugs/s40/a2976/.
5.      Covishield: WHO flags fake jabs in India, Africa, August 18, 2021 https://www.bbc.com/news/world-asia-india-58253488.
6.      The Truth Pill: The Myth of Drug Regulation in India, https://www.google.com.pk/books/edition/The_Truth_Pill/BhCMEAAAQBAJ?hl=en&gbpv=1.
7.      Mike Ives, Here’s What to Know About the Cough Syrup Scandal, October 21, 2022, The NYT, https://www.nytimes.com/2022/10/21/world/asia/cough-syrup-india-indonesia.html.
8.      WHO alert over India-made cough syrups after deaths in The Gambia, https://www.bbc.com/news/world-africa-63150950.
9.      Krishna N. Das, Exclusive: India probes bribery claim in toxic syrup tests, June 14, 2023, https://www.reuters.com/world/india/india-probes-bribery-claim-toxic-syrup-tests-2023-06-13/.
10.    Uzbekistan says 18 children die after consuming India-made syrup, December 28, 2022 https://www.aljazeera.com/news/2022/12/28/uzbekistan-says-18-children-die-after-consuming-india-made-syrup.
11.    Medical Product Alert N°8/2022: Substandard (contaminated) METHOTREX 50mg, December 27, 2023 https://www.who.int/news/item/27-12-2022-medical-product-alert-n-8-2022-substandard-(contaminated)-methotrexate.
12.    Joe Wallen, Alert over cancer drug containing life-threatening bacteria, March 28, 2023 https://www.telegraph.co.uk/global-health/science-and-disease/alert-cancer-drug-containing-life-threatening-bacteria/.
13.    Festus Poquie and Zachary R. Mider, Liberia Is Latest Nation to Find Tainted Medicine from India, June 14, 2023, Bloomberg, https://www.bloomberg.com/news/articles/2023-06-14/liberia-is-latest-country-to-find-tainted-made-in-india-medicine#xj4y7vzkg.
14.    Substandard (contaminated) syrup medicines identified in WHO Region of the Western Pacific, April 25, 2023, WHO, https://www.who.int/news/item/25-04-2023-medical-product-alert-n-4-2023--substandard-(contaminated)-syrup-medicines.
 15.   Global Pharma: FDA says India firm linked to US eye drop deaths broke safety norms, April 4, 2023, BBC, https://www.bbc.com/news/world-asia-india-65171851. 
16.    FDA Inspection Report, FDA, https://www.fda.gov/media/166739/download.