State drug regulators across the country are understood to be waiting to get further direction from the National Pharmaceutical Pricing Authority (NPPA), to implement the new drug pricing policy on the expiry of the 45 days time which ended on July 29, for the first batch of 151 drugs whose ceiling prices have been declared.

Though most of the drug regulators are ready to implement the new drug pricing policy they have decided to wait the matter for the time being, keeping in mind the interest of the patients. Adding to that factor is the Delhi high courts decision in favour of Cipla and Sun pharma which gave temporary relief to them on the controversial decision to enact the new pricing policy within 45 days of declaring the ceiling price.

Dr H G Koshia, commissioner of Gujarat FDCA informed that they have all the data on the drugs that have undergone price change and have taken precautionary measures to sensitise about this matter to all the stakeholders on their stand. However, he added that keeping in mind the larger interest of the patients who may be the end sufferer they have decided to take lenient approach in this matter by not acting tough.

“With more and more companies approaching the high court for their intervention in this matter, there is a lot of ambiguity prevailing over this subject as of now. Since we have received no clarification or any direction on how to proceed on this from neither the NPPA nor the judiciary, to safeguard the interest of the patients we are adopting a cautious approach, until further notice. Meanwhile, we have requested the companies involved in the petition to send the court order to give us better insights on the current status of this issue and the courts approach on the same for better clarity,” Dr Koshia added.

It is understood that, like in Gujarat other drug regulators from the states like Maharashtra and Goa are also taking a safe call in this issue keeping in mind the greater interest of the patients involved. Technically, though they are ready to initiate the implementation of the new drug prices for the first batch of drugs, recent reports suggest that they are resorting to precautionary measures by stalling the same to ensure that the patients do not suffer due to the lack of availability of life saving drug in the state.

A senior official from the Maharashtra (Maha) FDA informed that they already have all their officials on a stand by to take immediate action with respect to the implementation if needed. However, in light of the recent developments they have decided to go slow on this matter until further notice from the concerned authority. “While the implementation of the law is of utmost importance, so is the welfare and safety of the patients. We do not want the patients to suffer due to lack of availability of life saving drugs in the market under the prevailing state of chaos and confusion over the pricing matter. Thus we are waiting to get a clear direction on this matter and will proceed from there as required,” highly placed source from Maha FDA added.

Sources inform that the even drug regulatory officials from Goa are awaiting further direction from the centre to take further action on this matter. In the meanwhile it is understood that more companies are pondering over the possibility of approaching the court for their intervention to address the issue of 45 days time frame demanding that it is technically impossible to recall and re-label the drugs within such a short period which may result in the lack of availability of life saving drugs to the patients in the long run.