According to the data for April, most of these companies are making drugs that failed safety standards and have been found to be sub- standard quality.
As part of the continuous regulatory surveillance, drug samples are picked from sales and distribution points and analysed at various government run laboratories.
According to the drug regulatory authority, in April about 60 samples failed to meet the quality standards and have been declared as Not of Standard Quality (NSQ) Drugs.
Samples which failed tests are carboxymethylcellulose sodium eye drops, an eye lubricant, also known as artificial tears, bupivacaine hydrochloride injection, a local anaesthetic, calcium carbonate and vitamin D3 tablets, among others.
Interestingly, they have been manufactured at lesser known pharma companies like Gidsha Pharmaceuticals in Gujarat, Martin and Brown Biosciences in Solan, Himachal Pradesh, Sai Parenterals in Hyderabad, Nestor Pharmaceuticals, Faridabad, among others. These companies could not be contacted immediately.
“This has been the trend for some time now. Most of these MSME are found to be manufacturing drugs which are not of standard quality. That is the reason the health ministry came out with a notification which outlines standards for the pharma companies,” said a person with knowledge of the matter.
Earlier in 2023, over 65% of MSME enterprises were found to be manufacturing drugs that were not of standard quality (NSQ) during risk-based inspections (RBI) of pharma companies.
“Of the total MSME units inspected, 30% were issued stop production orders (SPO), while samples of 68% MSME companies have failed. This is alarming,” the person said.
The CDSCO and state drug inspectors have been conducting these inspections as part of a massive nationwide crackdown on spurious and substandard medicines. This followed a controversy over alleged Made-in-India cough syrups being responsible for the deaths of children in The Gambia.
The CDSCO has found that these companies have issues related to infrastructure, quality management systems and product manufacturing process knowledge.
“There has been a strong correlation between NSQ and the condition of manufacturing set up. Monthly NSQ data shows repeat failures for a company with the same product with multiple companies month on month,” another person said.
India’s drug regulator had earlier pointed to an urgent need to review the current GMP regulations and Quality Management Systems being followed by pharmaceutical companies during the RBI.
