Drug Controller General of India (DCGI) has started enforcing standards under Indian pharmacopoeia on imported drugs also as is the case of domestic products, amid apprehensions that some foreign multinationals were trying to evade Indian standard parameters while following the norms in their own countries.
DCGI has asked his drug inspectors across the country to make sure that all drugs imported and products manufactured by multinational companies here adhere to the standards set in the latest IP 2007. He has issued orders to zonal and sub-zonal offices of CDSCO to mount inspections on regular basis to verify if the imported drugs had followed the norms. Taking the matter very seriously, he also asked them to intimate the action taken in this regard to his office at an early date.
While most of the domestic manufacturers have already implemented the norms of Indian Pharmacopoeia 2007 after it was put into force from July this year, there were apprehensions whether multinationals followed the same with right earnest. Some in the domestic side pointed out that the multinationals took a lenient approach to Indian standards under the pretext of having complied with pharmacopoeia parameters in their own countries. The move by the DCGI thus is expected to arrest the misdoings in this regard and give a level-playing field to the Indian manufacturers.
"The standards to be complied with by imported drugs and by the drugs manufactured for sale, sold, stocked or exhibited for sale or distributed has been prescribed in the Second Schedule of the Drugs and Cosmetics Act 1940 and Rules there under which is self explanatory," the DCGI order said, asking officers to ensure strict compliance of provisions of the act in this regard.
The IP 2007 has already included drugs covered by USP, European Pharmacopoeia and British Pharmacopoeia so that imported drugs also could be monitored for the parameters. It has over 1500 monographs including new 300 monographs.
Meanwhile, Indian Pharmacopoeia Commission sources said the stakeholders had received the document well and most of them have implemented the same. The IP 2007 also got high appreciation from experts in countries like United States and Europe. The move by DCGI would make sure that all drugs now in the market, either by the domestic companies and or the multinational foreign players, would be as per the standards of IP, sources said.