 "pharma, medicine, drugs")
The government has identified a huge number of pharmaceutical companies in the micro, small and medium enterprise (MSME) sector that are manufacturing substandard drugs, a report by the Economic Times (ET) said.
A person with knowledge of the matter told ET that over 65 per cent of MSME enterprises were found to be manufacturing drugs that were not of standard quality (NSQ) during risk-based inspections of pharma companies undertaken since December last year.
"Out of the total MSME units inspected, 30 per cent were issued stop production orders (SPO), while samples of 68 per cent MSME companies have failed. This is alarming," the person said.
The Central Drugs Standard Control Organisation (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 Gambia.
Currently, Phase IV of the risk-based inspections is being conducted. During this process, the inspectors withdrew samples from 22 different companies. Out of the total 446 samples drawn, 271 were analysed.
"While 230 samples were found to be of standard quality, 41 were not of standard quality," the person was quoted as saying by ET.
"There has been a strong correlation between NSQ and the state of manufacturing set up. Monthly NSQ data indicates recurring failures for a company with the same product and same product with multiple companies month after month," a second person told ET.
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India's drug regulator had earlier pointed to an urgent need to review the current good manufacturing practices (GMP) regulations and quality management systems (QMS) being followed by pharma companies.
In August, Union Health Minister Mansukh Mandaviya announced that companies with a turnover of Rs 250 crore and more will have to implement the revised GMP within six months.
He said that MSMEs with a turnover of less than Rs 250 crore will be required to adopt it within a year, adding that companies that fail to follow the timeline may be penalised.
The GMP system was first incorporated in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and was last amended in 2005. Schedule M specifies the requirements for drug plants.
However, in September, several industry associations representing the MSME sector appealed to the health ministry and the drug regulator, saying the move would impact competition and drastically impact the availability of medicines.
