The Drugs Control Administration in Andhra Pradesh is still groping in the dark over fixed dose combination (FDC) issue as the state Director General (DG) of the drug department is yet to take a final decision as to whether to allow marketing of the 294 contentious FDC drugs or not in the state. After more than a month of the Madras high court stay order on the issue, the DG is now putting the ball in the state government's court to take a final decision on this controversial issue.
Refuting reports appearing in a section of the press that the AP drug authorities also have decided to allow marketing of the contentious 294 FDC drugs, Director General of Drugs Control Administration in Andhra Pradesh RP Meena said that the pharma association representatives and industry representatives misunderstood the initiative of the department. "We are working on collecting the details about the stocks available with the distributors and also the timeframe for liquidating them. We haven't so far given permission to market these products in the state", Meena categorically said.
He said that it is true that the department is collecting all the information regarding the size of the stocks of these 294 combination drugs lying with the C&F agents, distributors and at the retail level. The department is also asking the pharma manufacturers and the distributors about the timeframe by which they can liquidate these stocks. The drug administration had recently held a meeting in this regard in which representatives from industry and industry associations were also present.
Literally putting the ball on the state government's court, Meena said, "After collecting all the information, I will submit the report to the state government. Then the state government will decide whether to allow marketing of these 294 drugs or not in the state. After all, the state government is above me".
This is happening at a time when the state drug controllers in other states are taking independent decisions on their own. While in some states the drug authorities are sitting idle, states like Haryana has allowed marketing and even manufacturing of these products in the light of successive Madras high court stay orders.
Refuting the reports that the state drug administration has decided to release the drugs worth Rs 39 crore which the department had seized from different parts of the state since the implementation of the DCGI order against the FDC drugs, Meena said that the report was wrong. "It is still lying with the department and the state government will decide on the issue".
He said that the Andhra Pradesh Drugs Control Administration is strictly implementing the DCGI order against the FDC drugs and no manufacturer will be allowed to manufacture these drugs in the state unless and until he gets the license from the DCGI.
On the Madras high court stay orders, Meena said, "It is not expressive. There is no clarity in the order and I will seek the legal opinion on it".
It is a fact that there was a debate over the jurisdiction of the Madras high court stay orders. Even experts were divided over the issue. While some argued that the court stay should be applicable only to Tamil Nadu, others argued that since the court has stayed a central government order and therefore it has jurisdiction all over the country.
So far, the AP drug controller was subscribing to the view that the Madras high court stay orders are not bound on Andhra Pradesh and he has been strictly following the DCGI order. Apart from cancelling the manufacturing of all the 294 FDC products, the drug authorities in AP were not allowing the traders to market these products.