New Delhi: The Central Drugs Standard Control Organisation (CDSCO) detected 48 drugs of sub-standard quality in August with Himachal Pradesh and Gujarat accounting for the maximum manufacturers of producing drugs of poor quality. Significantly, the CDSCO has detected a total of 147 drugs of poor quality in the last three months. As per records, in July, the drug regulator detected 51 sub-standard drugs whereas in June as many as 48 drugs were found to be of sub-standard quality.
CDSCO is India’s premier drug regulator that controls the import of drugs, approval of new drugs, and clinical trials. The drug regulator tested 1,166 drugs in August out of which 1,118 were declared of standard quality. As many as eight drugs produced by Gujarat-based manufacturers and 10 drugs produced by Himachal Pradesh-based manufacturers were found to be of poor standard.
According to the documents, cough syrup and cefotaxime for injection by the Gujarat-based drug manufacturers were found to be of sub-standard quality. Many cough syrups are found contaminated with toxins. Gujarat-based manufacturers like Aan Pharma Private Limited, Medisky Pharmaceuticals Private Limited, Globela Pharma Private Limited, Norris Medicines Limited, Maan Pharmaceuticals Limited, Aarmed Formulation Private Limited and Gladios Products Private Limited were found to be producing drugs of poor quality.
A cough syrup and an anti-allergy syrup made by Norris Medicines Limited are found contaminated with toxins that have been linked to several deaths worldwide.
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Similarly, Himachal Pradesh-based drug manufacturers, including Alves Healthcare Private Limited, Tirupati Medicare Limited, Anrose Pharma, Symbiosis Pharmaceuticals Private Limited, Ultra Drugs Private Limited, Swiss Garnier Life Sciences, Standford Laborites Private Limited, T & G MEDICARE were found to be producing drugs of poor quality.
Several manufacturers from Himachal Pradesh, who were producing lactic acid capsules, were found to be of poor standard. Drug manufacturers from other States, including Telangana, Uttarakhand, Karnataka, Uttar Pradesh and Tamil Nadu, were found producing drugs of sub-standard quality. When contacted over this issue, Dr Giridhar Gyani, director general of the Association of Healthcare Providers of India (AHPI), said that the detection of poor quality drugs by CDSCO is a regular process following which the drug manufacturers are asked to improve their standards.
“Once a drug is found to be of sub-standard quality action is taken by not allowing the particular drugs to come into the market,” said Gyani. Admitting that India is a major exporter of drugs worldwide, it is the mandate of the CDSCO to properly check all drugs that go abroad. “On a few occasions it has been found that a cough syrup manufactured in India came under severe controversy in a few countries,” Dr Gyani said.
It is worth mentioning that since June this year, the Central government has made it compulsory for cough syrup makers to get samples tested before exporting their products. According to the notification, the companies have to get a certificate of analysis from a government-approved laboratory. The rule change comes after some Indian-made cough syrups were linked to deaths in Gambia, Uzbekistan and Cameroon.
