Medicare News, May 15, 2016: Honourable high court should call all regulators of all levels who gave approval to fixed dose combination without taking care whether it is clinically safe for human being or not. It is a criminal offence and all regulators involved in this menace should be punished immediately.
On the other hand all Pharma companies are equally irresponsible in this episode, they never bothered about safety concern of patients when rules are in place. Pharma covigilance system should be there within the premise of every company who got approval of fixed dose combination from state to monitor drug safety. Its a law of in India for drug safety that even if you have one drug approval in India, you have to have pharmacovigilance system.
Double, Triple negligence of drug approval authority in this menace, firstly they gave approval without following the legal system, secondly they never bothered to give workshop to Pharma companies about pharmacovigilance system master file, thirdly they are casually accepting periodic safety update report and further comments and lastly they are blaming Pharma companies. You are taking salary from public pocket for providing safe drug and giving consultancy privately to somebody else.
Now this hot topic is under the scanner of media and court hence you all are going against the industry and you are trying to prove yourself innocent.
Still there is room to control this menace. Join hands with Pharma industries, sit together and take combined steps to stop this menace once for all. Forget past, stop enmity and diplomacy, firstly punish who had given approval and give sufficient time to the industry at least one year to sale all stocks. Share list of drugs which is going to be ban in phase-2 so that industry people will be planned in advance and there will be no hue and cry.
The Delhi High Court restrained the government from enforcing a ban on hundreds of drugs for another week on Monday until it has heard petitions from drugmakers challenging the order, a lawyer representing some of the firms said. The health department prohibited the manufacture and sale of 344 fixed-dose combination drugs this month, citing experts as saying there was no medical justification to administer them.
Several companies, including Indian units of Abbott Laboratories and Pfizer Inc, and domestic firms like Cipla Ltd and Macleods Pharmaceuticals, went to the Delhi High Court to try to get the ban lifted.
On Monday, judge Rajiv Sahai Endlaw moved the hearing into his chamber from a courtroom packed with lawyers and company executives. Archana Sachdeva, a lawyer representing Cipla among other firms, said he had ordered the next hearing on March 28.
Abbott is challenging the ban on its popular codeine-based cough syrup on the grounds it was not given a chance to defend itself.
Combination drugs are used worldwide to improve patients’ compliance, as it is easier to get people to take one drug rather than several. But inconsistent enforcement of drug laws in India has led to hundreds of such medicines entering the market based on approval from regulators in individual states, rather than the central government.
Sanjay Jain, a lawyer representing the government, said he was trying to get the court to lift its order staying the ban on the drugs. “Commercial interests are not larger than public health,” Jain told reporters.