Karnataka drugs control department's drug test lab (DTL) has declared four drugs to be not-of-standard quality. The drugs are Nimpah -P which contain Nimesulide and paracetamol manufactured by CB Healthcare in Solan district in Himachal Pradesh, Pentisan tablet manufactured by Sanchez Laboratories in Solan district, Imol Plus produced by Ravian Life Sciences in Uttaranchal and absorbable surgical sutures of MCO Hospital in Hubli, Karnataka.
Three of the four drugs are produced at the former excise free zones in north India. There have been several complaints on the quality standards of these drugs manufactured at these locations The drugs were tested not only in Bangalore but also from the drug test lab at Vadodara.
The Drugs and Cosmetics (Amendment) Act, 2008 which came into effect from December 5, 2008 has provided clear cut guidelines on the penalties for offences when spurious or adulterated drugs are manufactured. This guideline help regulatory authorities to handle the violators. The penalty for manufacture of spurious or adulterated drugs include imprisonment for not less than 10 years and extend to life imprisonment. The violator is also liable for a fine amounting to not less than Rs 10 lakh or three times value of the drug confiscated. In some cases offences have been made cognizable and non-bailable, according to the state drugs control officials.
According to the Central Drugs Standard Control Organization (CDSCO) report, the Drugs and Cosmetics Act, 1940 called for legal or administrative actions which are initiated on the basis of test reports by the government analysts declaring the drug samples as not of standard quality. A drug is declared as not-of-standard quality if it resembles another drug, or not contain the active ingredients or if manufactured by a company which does not possess license.
Drugs are declared grossly sub-standard if active ingredient content is below 70 per cent for thermo labile products and below 5 per cent of the permitted limits for thermo stable products. Other yardsticks to measure the not-of-standard quality are tablets or capsules failing the disintegration and dissolution tests.