Karnataka drugs control department has urged the Drug Controller General of India (DCGI) to upgrade its status from the existing sub zone office to zonal office. The upgrade will provide considerable benefits to the 236 pharma companies in the state.  

In this regard, the DCGI has been positive about the request and we expect the upgrade from the existing sub zone office to zonal office status in the next few months, Karnataka drugs controller Dr. B R Jagashetty told Pharmabiz.

Following the latest communiqué by the Ministry of Health and Family Welfare for the setting up specially designated courts for speedy trial of offences under the Drugs and Cosmetics (Amendment) Act 2008, in a bid to tackle the problem of spurious drugs, Dr. Jagashetty said that Karnataka drugs department was way ahead in terms of adopting measures to ensure transparency and efficiency. “In fact, Karnataka is the first state in the country to put in place 30 Special Courts at all its districts to undertake the trial of offences related to adulterated and spurious drugs as provided in the Drugs & Cosmetics (Amendment) Act 2008. The hearings are taking place. There is speedy disbursal of cases,” he added.

The section 32B based on the Code of Criminal Procedure in the Drugs & Cosmetics (Amendment) Act 2008 deals with offences for imprisonment with fine. Section 36 AB asserts establishing a special court to undertake the trial of the offence where the central or state government in consultation with the chief justice of the High Court would examine the offences related to spurious and adulterated drugs.

Specifically, the Karnataka drugs control department has been aggressive in carrying out surprise inspections, delivering online issue and renewal of licenses for pharmacy outlets and manufacturing units. There are also third party inspections involving public and non-governmental organizations. It has three drug testing laboratories at Bengaluru, Hubli and Bellary. In November 2012, 42 HPLC’s  were installed under a World Bank funded Karnataka Health System Development and Reform Project (KHSD&RP) and recruited 52 junior scientific officers who underwent training prior to their induction into the labs.  The state is also the third after Maharashtra and Gujarat in having highest good manufacturing compliant facilities too. All these factors highlight our capabilities and a zonal office status is much wanted, informed Dr. Jagashetty.

From 2009, Dr. Jagashetty has been insisting for Good Distribution Practices (GDP) to check the prevalence of substandard drugs because of  poor storage conditions  across scores of pharmacy outlets in the  country.

It was in February 2010, the Centre had expressed its plan to set up special courts in Mumbai, Ahmedabad, Chandigarh, Chennai and Hyderabad. Now the government has mandated need for special court  but now Karnataka is at the forefront in this regard.“The  government, regulatory authorities and industry need to be proactive  to combat the menace of counterfeit and spurious drugs,” stated Dr Jagashetty.