The Confederation of Indian Pharmaceutical Industries (CIPI), which moved the Madras high court and received stay orders on former DCGI's directive against the FDC drugs, is willing to withdraw the cases if the new DCGI agrees to allow licenses to the 150 FDC drugs which were categorised as 'need further examination'.
"If the new DCGI agrees to issue licenses to the 150 FDC drugs which were categorised as 'need further examination' by former DCGI Dr M Venkateshwarlu, we will definitely consider withdrawing the cases filed in the Madras high court", said CIPI chairman T Jaishankar. A CIPI delegation led by Jaishankar will soon meet the new DCGI Dr Surinder Singh to discuss these issues.
Moving away from its earlier steadfast stand that the association will fight it out in the court, the CIPI chairman said, "We are not fighting against the government. It is a question of survival of the industry and thousands of crore of rupees are at stake. If the new DCGI is willing to shed the rigid stand taken by his predecessor, we will definitely reciprocate by offering him to withdraw the cases".
Ever since former DCGI Dr Venkateshwarlu embarked upon his campaign against irrational combination drugs in June last year, the industry was insisting that it should be allowed to manufacture and market at least the 150 'need further examination' drugs on the plea that there is no data to prove that these combination drugs are irrational and are unsafe for human consumption. The industry had then demanded that these drugs should be examined by an expert technical committee like DTAB to find its safety and efficacy before initiating any action. But, the former DCGI did not move from his stand, forcing the industry to move court.
After directing the state drug authorities to withdraw licences issued by them to the combination drugs, the DCGI had identified 294 FDC drugs for action and he had put these drug in different categories like Absurd, Rejected, Banned, Under Examination, etc. The industry associations have more or less agreed to discontinue around 120 products falling under Absurd, Rejected and Banned categories. In the 294 FDC drugs, 150 were 'need further examination category.