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Experts say quality issues on the rise as foreign testing labs bypass testing method of patent or proprietary medicines
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Shardul Nautiyal, Mumbai
August 16 , 2023
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Alarmed at the waning credibility of India as a major pharma exporter globally, state drug control authorities and experts have observed that quality issues in medicines exported from India is on the rise because foreign testing labs are bypassing in-house testing methods and validated methods of analysis of patent or proprietary medicines.
“Patent or proprietary medicines are tested based on a certain set of in-house testing methods and validated methods of analysis which are available only with the drug manufacturing company and not currently available in any pharmacopoeia globally,” experts reveal.
Talking about the growing number of quality issues India currently faces, Gujarat Food and Drug Control Administration (FDCA) commissioner Dr H G Koshia says that testing should be done in labs like the highly equipped and advanced Vadodara based lab which is also the largest in Asia spanning an area of 15, 157 square metres built up area. The lab is National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited and collects over 15,000 samples under different categories including proprietary or patent medicines annually.
“Our scientists and lab technicians either ask for manufacturers’ in house testing method or validated method of analysis and then develop it independently based on their expertise. This results in getting authentic test reports which have no element of doubt or ambiguity,” Dr Koshia further explained.
The World Health Organization (WHO) had also issued a product alert on one more cough syrup manufactured by an Indian company on August 7, 2023 in Iraq. The WHO had said that one batch of substandard Cold Out syrup with paracetamol and chlorpheniramine maleate was identified in the Republic of Iraq and reported to the Organization on July 10, 2023 by a third party.
“Patent or proprietary medicines means any medicinal preparation which bears either on itself or on its container or both, a name which is not specified in a monograph in a pharmacopoeia, formulary or other publications notified by the Central Government in the Official Gazette. These medicines include packaged medicines, drugs, medical and dental supplies, and bottled or non-bulk chemicals identified by and sold pursuant to a trademark,” as per law of the land.
According to reports, the sample in Iraq was collected by Bloomberg News and tested by an independent laboratory. The agency reported the test result to the WHO, which in turn issued the alert.
The incident comes at a time when WHO has earlier warned about samples of cough syrups and other medicines manufactured in India and exported to some countries as substandard. This has raised alarm against Indian exports and had an impact on the reputation of the country.
While WHO states that these products are contaminated, the Indian regulator has earlier said that samples of at least one of the companies against whom the alert was raised has been found as not contaminated in the tests it conducted.
The Central Drugs Standard Control Organization (CDSCO) and the state drug regulators have swung into action to identify the gaps and quality issues.
Cases of contaminated cough syrups exported to Gambia, Uzbekistan and the recent WHO alert of contaminated cough syrup issue in Iraq has again prompted authorities to increase nation-wide risk based inspections. Operations of around 40 drug manufacturing firms have recently been halted based on inspections in 162 firms.
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