Trademark infringement, drug sales without receipts, raw material purchases without receipts, problems with quality control, the production of counterfeit medications, and other concerns were discovered as a result of India’s extensive investigation into the issues in the drug manufacturing industry.
India takes forward extensive investigation into the issues plaguing the Drug Manufacturing Industry
Six teams have reportedly been formed to audit and raid identified drug manufacturing facilities with the state drugs control administration using a risk-based strategy, according to sources in the health ministry.
Committee comprising two joint drug controllers at Central Drugs Standard Control Organization (CDSCO) to monitor the process of inspection, reporting and subsequent action
To oversee the process of inspection, reporting, and follow-up action, a committee of two joint drug controllers has been established at the top drug regulation organisation, Central Drugs Standard Control Organization (CDSCO). Dr. Mansukh Mandaviya, the union minister for health and family welfare, is the one who initiated the action. It follows the World Health Organization’s (WHO) accusation that the Indian company Maiden Pharmaceuticals exported tainted medications that killed Gambian children.
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Results of India’s Massive Efforts to Clean up the Pharma
Himachal Pradesh, recognised as the centre of Indian drug manufacturing, has so far conducted raids at more than 12 facilities, and there are still further inspections to come. Companies who were found to have violated good manufacturing procedures have been given show-cause notices. Manufacturing has been fully halted at one facility, according to Navneet Marwah, HP’s drug controller. Marwah added that the bulk of these businesses are “small and medium enterprises,” but he would not provide the names of the defaulter companies.
India-wide inspections, including those in Himachal Pradesh, are currently ongoing. A second government source familiar with the situation claimed that “Solan, an HP-based company, was making life-saving medications but selling them without invoices and even the acquisitions of APIs (raw ingredients) are without bills.”
Pharma industry’s reputation harmed by rampant trademark infringement, noncompliance with good manufacturing practices (GMP), and nonstandard quality reports
The same source claimed that another HP company “manufactures various brands in the name of the main brands, which amounts to trademark infringement and can be regarded fraudulent.” Another company, HP, was also discovered to be breaking the law. HP produces a number of goods for a well-known international pharmaceutical company. The Greater Noida raid in Uttar Pradesh uncovered a well-known pharmaceutical company operating a wellness-related subsidiary company. The source added, “However, they did not have any drug licence but cashed the brand name.He added, “The company’s owner was named in one of the major bribery allegations as well.
Despite producing essential pharmaceutical injections, the Dehradun-based medicine manufacturing facility in Uttarakhand was found to be in violation of good manufacturing principles. Due to the pending non-standard-quality reports of the most recent samples selected (in certain cases) and “unnecessary alarm in the industry,” the officials asked that the names of the drug manufacturers be hidden.
How the list of Pharma Companies to audit was compiled
Prior to conducting inspections, an action plan for the nationwide inspection of manufacturing facilities that are suspected of producing medications that are not of standard quality (NSQ), are adulterated, or are bogus was created. According to a government news release issued on Tuesday, “the goal of drug regulation is to ensure safety, efficacy, and quality of the pharmaceuticals available in the country.” “The Drugs & Cosmetics Act, 1940 and Rules thereunder, particularly with respect to the requirements of Good Manufacturing Practices (GMP)” are required to be followed by manufacturing facilities.
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