In the backdrop of the amendment to the Drugs and Cosmetic Act in 2008 which  enhanced the penalties on manufacturing of spurious and substandard drugs, the regulatory authorities are planning to review the existing parameters and quantum of penalties with regard to the major and minor offences.

An expert committee is learnt to have been set up to prepare guidelines to make discrimination in major and minor offences. Deputy Drugs Controller (North Zone) Dr D Roy will head the panel which has the Drugs Controllers of Maharashtra, Rajasthan and Odisha as the members. The panel is expected to submit the report within a month, sources said.

According to the existing provisions, Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Rules, 1945, make no discrimination in major and minor offences. Thus, the decision of taking administrative action or launching prosecution is left on the discretion of drugs controller or drugs inspector who remain under external pressure.

As per the guidelines by the Central Drugs Standard Control Organisation (CDSCO), the major and minor offences have been categorized in detail and the States are following the same. But the quantum of penalty or administrative action is still missing. The matter was raised by different State drug controllers, prompting the authorities to look at it afresh and prepare guidelines.

After the Parliament passed the Drugs and Cosmetics (Amendment) Act, 2008, the CDSCO had issued guidelines for taking action on samples of drugs adulterated. Adulterated and spurious drugs were categorized in Category A while `grossly substandard drugs’ fell under Category B. The Category C listed the minor defects.

However, the clarity was missing on the quantum of punishment for major and minor offences, though the Act enhanced the penalty upto 10 years of imprisonment and leaving the task to the drug controllers.