Karnataka drugs control department has declared nine drugs as not-of-standard quality. These drug samples were seized at random checking by the drug inspectors from pharmacy outlets in the state.

The drugs are diclofenac sodium injection IP (Diclolab) manufactured by the Laborate Pharmaceuticals at Himachal Pradesh, cronodol disulfiram tablets in 500 mg manufactured by Syncom Healthcare in Uttarakhand, Betonin –XT, a multi vitamin and mineral softlet manufactured by Geltec in Bangalore, Gamma Benzene Hexachloride by Pharma Asia in Madhya Pradesh, paracetamol tablets by GS Pharmaceuticals in Uttarakhand, Mecovit OD capsules by Surien Pharmaceuticals in Puducherry, Domperidone syrup by Saar Biotech in Himachal Pradesh, RBX 20 or Rabeprazole sodium tablets by Healthcare Formulations in Baroda and  Cipros -500 tablets manufactured by Cu-V-Kar Genetic Medicines at Uttarakhand.

The state drugs control department has issued alerts to the pharmacy outlets, hospital pharmacies, medical practitioners and public to refrain from selling, prescribing and purchasing these medicines. The department has cautioned chemists to hand over the stocks of these drugs if any to the drugs inspectors or assistant drugs controller.

The drugs have been tested at the Drug Test Lab in Bangalore belonging to state drugs control department. According to Dr BR Jagashetty, Karnataka Drugs Controller, the regular, surprise inspections and testing medicine samples at random will allow the public to have access to quality drugs.

A drug is found to be not-of standard quality due to factors like poor storage conditions and faulty packaging. The drug would be manufactured by the company adhering to Schedule M norms, but during transit and storage in harsh temperature conditions, the contents of the formulation are known to deteriorate and disintegrate, he added.

The drugs department is also gearing up to launch the drug sampling project covering the entire state and is currently awaiting for funds from the state government. Under the initiative, which will be carried out in all the 30 districts via 36 circles across the State, would involve public, non-governmental organizations and consumer forums. The project will see drug samples being drawn from retail/wholesale outlets at random and tested at various approved labs to verify whether they are spurious or substandard. Even the test and analysis would be carried out in the presence of public, non-governmental organizations and consumer forums, Dr Jagashetty stated.

Now with the Drugs Controller General of India (DCGI) planning to set up a committee to oversee the formulation of guidelines for the Good Distribution Practices (GDP), the importance of inspections to look for good quality drugs comes to the fore. In fact, Karnataka Drugs Controller had been insisting that Drugs & Cosmetics Act should add a new Schedule for GDP. With the presence of not-of standard quality drugs, the need of the hour is a specific guideline calling for  recall, discard and destroying of date expired drugs, substandard and defective packaged products, he said.