New Delhi: India’s premier drug regulator, Central Drugs Standard Control Organisation (CDSCO) found 59 drugs manufactured by different pharma companies across the country of substandard quality in February. As per government statistics in possession of ETV Bharat, the CDSCO tested 1,251 drug samples in February out of which 1,192 were found to be of standard quality and 59 drugs of substandard quality.
The drugs were tested by the seven Regional Drugs Testing Laboratories (RDTL) and Central Drug Testing Laboratory (CDTL) of the national drugs testing laboratories of the Central Drugs Standard Control Organisation stationed across the country. The RDTL Guwahati has detected 16 drugs, 29 drugs were detected by the Kolkata-based RDTL, three drugs were detected as substandard by Chennai RDTL, four by Mumbai CDTL, three by Hyderabad CDTL and four by Chandigarh CDTL.
Drugs like OMICERR -20 (Omeprazole Capsules IP), Levocetirizine Tablets IP Levotac, Levocetirizine Dihydrochloride Syrup, 30ml, RL 500 ml, Compound Sodium Lactate Injection IP (Ringer Lactate Solution for Inj), Zinc Sulphate Dispersible tablets IP 20 mg, Olben Cream (cream for dry skin), Calcium and Vitamin D3 tablets IP were some of the drugs sound as sub-standard.
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Being the prime drug regulator in the country, CDSCO keeps testing drugs and medicines manufactured by different pharma companies. The detection of 59 sub-standard drugs comes at a time when the Union Health Ministry has launched a massive crackdown against pharma companies involved in the ‘illicit’ drug business. Under the Drugs and Cosmetics Act, of 1940, control over the manufacture and sale of drugs is exercised by the State Licensing Authorities. Licences for drug manufacturing establishments and sale premises are granted by the said authorities.
“Inspections and raids are carried out by the Drug Inspectors appointed by the States to ensure compliance with the conditions of licences. Samples are drawn by Drug Inspectors to check the quality of drugs marketed in the country. Legal and administrative actions as required under the said Act and Rules for the violation of the provisions of the Act are taken by the State Licensing Authorities. The action is normally initiated based on test reports of government analysts declaring the drug samples as not of standard quality,” an official said.
