Indian pharmaceutical company Maiden Pharmaceuticals Ltd, whose cough syrups were found to be contaminated, likely killing 66 children in The Gambia, had requisite permission to export the drugs from a state licensing authority in India, the Union ministry of health and family welfare said on Thursday.
“The State Drug Controller had given licenses to the said Company only for export of these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Further all these 04 drugs manufactured only for exports by M/s. Maiden Pharmaceuticals Limited are not licensed for manufacture and sale in India. In effect, none of these four drugs of M/s. Maiden Pharmaceuticals is sold domestically in India,” the ministry said.
Since the manufacturing unit is in Sonepat, Haryana, the licence was issued by the local regulator there.
According to people familiar with the matter in the government, the regulations governing India’s drugs licensing practice are strict and adhere to World Health Organization norms.
“Not just the relevant data but also manufacturing practices are carefully inspected when licenses are issued for sale and distribution, including drugs that are meant for export purposes. India’s regulations are on par with global standards, which incudes WHO norms,” said a senior official in the regulatory division, asking not to be named.
{{/usCountry}}“Not just the relevant data but also manufacturing practices are carefully inspected when licenses are issued for sale and distribution, including drugs that are meant for export purposes. India’s regulations are on par with global standards, which incudes WHO norms,” said a senior official in the regulatory division, asking not to be named.
{{/usCountry}}WHO has a Prequalification of Medicines Programme (PQP) to ensure medicines supplied by procurement agencies meet acceptable standards of quality, safety and efficacy. Many countries use WHO prequalification as a criterion to directly import drugs.
PQP also prequalifies active pharmaceutical ingredients and quality control laboratories.
The manufacturer provides a comprehensive set of data about the quality, safety and efficacy of the product submitted for evaluation. This includes data on the purity of all ingredients used in manufacture; data on the finished pharmaceutical product (such as information about stability); and results of bioequivalence tests (clinical trials conducted in healthy volunteers), unless waived.
A team of assessors evaluates all the data presented, and a separate team of inspectors verifies the manufacturing sites for the finished pharmaceutical product, and its active pharmaceutical product and its active pharmaceutical ingredient comply with WHO good manufacturing practice.