Absence of a formal order from Drugs Controller General of India (DCGI) and shortage of drug inspectors are dissuading the states of Gujarat, Tamil Nadu, Andhra Pradesh, Maharashtra and Karnataka to take on the responsibility to conduct inspection of companies engaged in human studies.
The states of Gujarat, Tamil Nadu, Andhra Pradesh, Maharashtra and Karnataka are known to conduct the largest number of human studies in the country.
Clinical trial organizations in the country are questioning how the state drug controllers could carry out the inspections when the Drugs & Cosmetic Act (D&C Act) and Schedule Y clearly indicate that such an audit comes only under the purview of DCGI and the state drugs control inspectors have no role to play.
“The announcement is sending wrong signals to global companies as India is the hub for many international multi-centric human studies,” they said.
There is also need for a dedicated team of enforcement officers to undertake inspections. Further, there is need for training and comprehension on the different levels and intricacies of human studies which are carried out across hospitals and companies at their approved premises. Currently, the state drugs control departments in the country do have the right personnel and are bogged down by regular pharmacy outlet and pharma manufacturing site inspections, pointed out officials from clinical trial companies.
Drugs controllers from Gujarat, Tamil Nadu, Andhra Pradesh have categorically stated that the assertion by the DCGI to make the state regulatory departments to check out the sites of clinical trials and assess human studies is not an area of their specialisation.
According to Dr H G Koshia, commissioner, Gujarat FDCA, there are no appropriate rules and regulations asking the state regulatory departments to embark on this inspection of clinical trials.
“Unless and until we get an official communiqué from the DCGI, we will not take up the inspection of clinical trials of companies,” informed R P Thakur, IPS, director general of Andhra Pradesh Drugs Controlling Authority.
“Clinical trials do not come under the sphere of the State drugs control department operations and therefore there is no business for us to undertake audits or inspections of these companies,” said G Selvaraj, Drugs Control Director, Government of Tamil Nadu.
In May 2011, the Karnataka government’s medical education minister S A Ramdas had planned to temporarily ban clinical trial and research projects in all government hospitals and colleges, until proper guidelines were framed at a state level. But the order was lifted as the companies conducting the human studies came down heavily and called for immediate inspection of their premises. Eventually, the state government immediately lifted the ban.
Pharmabiz had earlier reported that Dr BR Jagashetty, drugs controller, government of Karnataka too had stated, “No state drug control departments in the country had been involved in inspection of companies engaged in clinical trials. Without empowerment under the D&C Act & Rules, there was no question of inspection.”