NEW DELHI, Mar 28: Following a massive nationwide crackdown for allegedly manufacturing spurious and substandard medicines, the licenses of 18 pharma companies have been cancelled and some firms have been directed to stop manufacturing on the account of poor-quality medicines, an official spokesman said on Tuesday.
Earlier this month, the Centre inspected 76 pharma companies and 26 of them have been served a show-cause notice. The majority of the companies were operating out of Himachal Pradesh, Madhya Pradesh and Uttarakhand.
Licenses of 18 pharma companies have been cancelled and they have been asked to stop manufacturing. Show cause notices have also been issued to 26 pharma companies, sources in the Union Health ministry said. The orders came as part of an ongoing crackdown on pharma companies amid reports of spurious drugs from India being sold abroad.
The Drugs Controller General of India had conducted inspection on 76 pharmaceutical companies. The surprise inspections were conducted by central and state teams and action was taken in 20 states. The campaign has been on for about 15 days.
The raids come amid reports of deaths and illnesses from Indian drugs from several nations. Last month, Gujarat-based pharma company Zydus Lifesciences recalled more than 55,000 bottles of a generic medication used to treat gout from the US market. The medicine had failed impurities specifications.
In Noida, near Delhi, three employees of a pharmaceutical firm were arrested after their cough syrup allegedly led to the death of 18 children in Uzbekistan last year. They were accused of manufacturing and selling adulterated drugs.
The Central and Uttar Pradesh drug authorities had checked samples of Marion Biotech products and found 22 of them “not of standard quality” (adulterated and spurious). Also in February, a Chennai-based pharmaceutical company had to suspend production of a line of eye drops after US health authorities said they could be contaminated with a drug-resistant bacteria that have been linked to reports of permanent vision loss and one death.
EzriCare Artificial Tears eye drops, manufactured by Global Pharma Healthcare, was apparently linked to cases of Pseudomonas Aeruginosa, which affected at least 55 people in the US.
A Health Ministry source said there had been a cancellation of product permission of three companies. This was Phase-1 of the campaign wherein 203 pharma companies have been identified and action was taken on 76 companies.
“A joint team of the Central and State government conducted the inspection and the special drive is aimed at stopping the production of adulterated drugs and ensuring good manufacturing norms compliance,” said the official.
The World Health Organization (WHO) had in October last year warned against four cough syrup and medicines for cold being manufactured by Sonepat-based Maiden Pharmaceuticals- Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough, Syrup and Magrip N Cold Syrup. These were identified as “substandard products” allegedly containing two toxic compounds — diethylene glycol and ethylene glycol.
(Manas Dasgupta)
