The industry has taken exemption to the ongoing exercise of by the Drugs Controller General of India (DCGI) to examine the safety and efficacy of allegedly unapproved fixed dose combinations (FDCs), without getting the stay by the court vacated on the original order in this regard.
Reacting to the recent development of setting up expert panels to examine the applications for over 5000 formulations, industry leaders termed the exercise as 'futile' and 'eye wash' as long as the stay on the order was in force. They also alleged that the DCGI was not serious in this regard as the government did not try to vacate the stay granted by the Punjab and Haryana High Court.
The Central Drugs Standard Control Organisation (CDSCO) has recently constituted 10 expert committees to examine the huge number of applications for regularization of FDCs, received in response to the instruction by the DCGI to the manufacturers to prove the safety and efficacy of those FDCs permitted without due approval from his office. The DCGI has also asked the manufacturers to submit additional documents, if they had not submitted earlier with their applications so that the same may be included along with the applications for examination by the expert committee.
First, the Himachal Pradesh High Court put an interim stay on the deadline of September 30, 2013 set by the DCGI to submit the applications. Later the Punjab and Haryana HC stayed the controversial order of 15.01.2013 that asked the manufacturers to submit safety and efficacy data of FDC drugs which were approved by the state drug controllers before October 1, 2012 without the DCGI nod.
Commenting on the issue, Himachal Pradesh Drug Manufacturers Association general secretary S L Singhla felt that the current exercise did not have any relevance. “The applicants if they desire can even withdraw the applications and take the money back as the court had already stayed the very order by the DCGI. The Government has not approached the court to vacate the stay yet,” he said. The Himachal association had first approached the HC on the issue.
Another industry leader, who did not want to be named, termed the DCGI attempt as 'eye wash' and 'futile'. “The government did not want to vacate the stay by the Madras High Court even after six years. Now, through the new order, they have mopped out some money. They know that some of these FDCs have been in the market for over four decades now,” he said.
“The State Drug Controllers were requested by vide letter of even number dated 15.01.2013 that manufacturers are required to prove the safety and efficacy of such FDCs which are licensed by State Licensing Authorities without prior approval of DCGI before the office of the DCGI within 18 months. In this connection, a subsequent letter was issued on 05.07.2013 and 26.08.2013 that in order to examine the safety and efficacy of such FDCs in timely manner, the manufacturer should submit the application to the office of the DCGI or the respective zonal/sub-zonal officers of the CDSCO by 30.08.2013 in Form 44 along with requisite fees and supporting documents,” a notice by the DCGI recently said.