Govt's Crackdown On 76 Pharma Companies & What It Symbolises
Following an inspection by the Drugs Controller General of India (DCGI) on 76 enterprises across 20 states, the government on Tuesday revoked the licences of 18 pharmaceutical companies for allegedly producing fake medications.
As per a media report, three companies' permission to manufacture specific products was also cancelled. Show cause notices were issued to 26 companies after inspections by joint teams of central and state drug control offices.
"Huge crackdown underway on pharma companies across the country related to manufacturing of spurious medicines," news agency ANI tweeted quoting sources.
The tweet also conveyed, "Action on 70 companies in Himachal Pradesh and 45 in Uttarakhand and 23 in Madhya Pradesh during the government crackdown on companies manufacturing spurious medicines.”
What It Symbolises
Medicine is related to public health and India has more than 10,500 pharma companies and the companies that make spurious medicines will not be spared, said Union Minister of Health and Family Welfare, Mansukh Mandavia after the crackdown on pharma companies.
"For inspections, we have drug controllers in each state along with the Drugs Controller General of India (DGCI). If we find spurious medicines anywhere, we will take action against that company," the minister added.
Experts from the industry view this action as India's attempt to reinforce itself as a significant player in the global pharmaceutical industry by offering high-quality medications at affordable pricing.
"Any violation of good manufacturing practices (GMP) is a public health hazard. It is important to ensure patients can access breakthrough innovations while upholding ethical codes and maintaining strict regulatory standards. This is crucial to maintain patient safety and trust. In line with this, we should follow the highest levels of global ethical codes, and business practices, based on the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) and IFPMA code of conduct," said Vivek Sehgal, Director General, Organisation of Pharmaceutical Producers of India (OPPI).
Show cause Notice To E-Pharmacies
Previously, the Drug Controller General of India (DCGI) issued show cause letters to a number of online pharmacies, including Netmeds, Tata 1mg, and PharmEasy, last month for allegedly conducting business in violation of the 1940 Drugs and Cosmetics Act.
To counter the issue of counterfeit drugs, while making basic information about the drug available to patients, the Drugs Technical Advisory Board (DTAB) has recommended introducing QR codes in drug products to help authenticate and track and trace these drugs across the supply chain.
Reflecting on the mitigation of spurious drugs, Sehgal explained that technology-aided solutions and forward-looking steps can help address the drug quality challenge. "Moreover, the adoption of blockchain-based pharma solutions to ensure higher quality control across the value chain – vendors, distributors, bottling and packaging, and retailing should also be considered," Sehgal added.
Cases Of Counterfeit Drugs & Fatalities Worldwide
Indian pharma companies encountered setbacks after drugs made by Indian pharmaceutical firms were suspected of being responsible for fatalities in other nations.
The deaths of 70 children in the Gambia have been attributed to four syrups produced by Maiden Biotech, a company headquartered in Haryana. In an investigation into the subject, the Central Drugs Standard Control Organization (CDSCO) of India discovered that 22 out of 36 samples were "not of standard quality" (adulterated and spurious).
The deaths of 18 children in Uzbekistan have been attributed to two syrups produced by Marion Biotech, a company based in Noida. The Noida police detained three senior Marion Biotech employees after an FIR was filed accusing them of producing and dispensing contaminated pharmaceuticals.
A similar incidence involved an eyedrop from a company in Chennai that was related to 55 adverse events, including eyesight loss and one death from a bloodstream infection in the United States. An inspection was done and eyedrop production was halted at the site after which the company voluntarily removed its product from the market.
Requisite Regulatory Abidance
In February, at a chintan shivir, the health ministry with drug regulators and other stakeholders had addressed the possibility of imposing a time limit for implementing Schedule M of the Drugs and Cosmetics Act, which specifies good manufacturing practices.
As per media reports, the schedule is already in place, but the companies hardly adhere to it and even fewer follow the stricter WHO-GMP standards.
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