Infringement of trademarks, selling drugs without bills, buying raw materials without invoices, quality compliance issues and manufacturing fake medicines and more – this is what India’s massive drive to unearth the problems in drug making found.
According to the sources in the health ministry, six teams have been formed to conduct the audits and raids at identified drug manufacturing units along with the state drugs control administration as per a risk-based approach.
A committee of two joint drug controllers has been constituted at the apex drug regulation body, Central Drugs Standard Control Organisation (CDSCO), to monitor the process of inspection, reporting, and subsequent action.
The move is driven by the union minister of health and family welfare, Dr Mansukh Mandaviya.
It comes after the World Health Organization (WHO) blamed Indian company Maiden Pharmaceuticals for exporting contaminated medicines leading to the deaths of Gambian children.
Findings in India’s big drive to clean pharma
Himachal Pradesh, known as the hub of drug manufacturers in India, has raided more than 12 units so far with many more inspections pending.
“Show-cause notices have been issued to the companies where good manufacturing practices were found to be flouted. At one unit, manufacturing has been completely suspended,” Navneet Marwah, HP’s drug controller, told News18.com.
While Marwah declined to share the name of the defaulter companies, he said that the majority of these firms are “small and medium enterprises.”
The inspections are still going on across India including in Himachal Pradesh.
However, another government source privy to the development told News18.com that “Solan, an HP-based company was manufacturing life-saving drugs but selling them without invoices and even the purchases of APIs (raw materials) are without bills.”
Another firm in HP, the same source said, “manufactures several brands in the name of the leading brands which amounts to infringement of trademarks and can be treated spurious.”
“The owner of the firm was named in one of the major bribery controversies as well,” he said.
Another firm HP, which manufactures several products for a popular multinational drug maker, was also found to be flouting rules.
During the raid in Uttar Pradesh’s Greater Noida, a well-known pharmaceutical firm was found running a sub-firm under the wellness category. “However, they did not have any drug licence but encashed the brand name,” said the source.
Uttarakhand’s Dehradun-based drug manufacturing unit was found non-compliant with good manufacturing practices but manufactures critical pharmaceutical injections.
The officials requested masking the names of the drug makers due to the pending non-standard-quality reports of the latest samples picked (in some cases) and “unnecessary panic in the industry.”
How the list of companies to be audited was created
An action plan for nationwide inspection of manufacturing units that are identified to be at risk of manufacturing Not of Standard Quality (NSQ)/adulterated/spurious drugs) was made prior to carrying out inspections.
“The objective of drug regulation is to ensure safety, efficacy, and quality of the drugs available in the country,” the government press release issued on Tuesday said. “The drug control administration is required to ensure that manufacturing units comply with Drugs & Cosmetics Act, 1940 and Rules thereunder especially to the requirements of Good Manufacturing Practices (GMP).”
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