By Udumula Sudhakar Reddy
Both Telangana and Andhra Pradesh do not have any real time mechanism to track and trace drugs that are manufactured, distributed and sold in their markets.
Lack of proper IT supported infrastructure is making the job of the Drug Control Administration tedious and it has to depend on manufacturers, distributors and retail pharmacists for information.
During the recent recall of 344 banned recombination drugs, it had become a herculean task for the drug control authorities of both states. AP Drug Control Authority (DCA) is now thinking of developing a software to track and trace drugs based on their batch numbers and brand names, from place manufacture to the point of retail sales.
Director general of AP DCA A. Ravi Shankar said, “When we or any other monitoring agency find any drug that has gone wrong we need to immediately recall them with the help of the batch numbers and name. However, it is an uphill task to track down these drugs. We are now developing a software and a central server that will store details of all drugs. Tracking can be done on real time basis so that it is easy to withdraw the drug from the market quickly.”
He added the software could be useful for all drug control administrations across the country. An AP DCA official said, “Dealers are already uploading the purchases made for paying sales tax to the server of the Commercial Taxes department. But the value of the drugs will not help us track them. Now they need to upload batch numbers, quantity and brand names on the servers of DCA so that they can be tracked and traced. This will be tedious for the dealers but in view of public health, it is necessary.”
Andhra Pradesh DCA officials said have instructions been given to all field officers whenever something goes wrong regarding a drug. “Our staff literally works along with the distributors and makers to trace the defective batch. Now the instructions can be given to specific field officers to recall a drug.”
Many Pharma companies win stay orders
Many pharma companies have obtained stay orders regarding 230 of the 344 banned recombination drugs. The Delhi High Court has granted stay to companies that approached it. Drug control authorities of AP and TS are withdrawing the remaining drugs from the market and also of those companies who didn’t get stay orders.
A drug control administration official said, “The India Drug Manufacturers Association approa-ched the court seeking a stay on the ban on recombination drugs produced by other companies. However, the High Court refused to grant a blanket stay. So it is very complex. There is neither a blanket stay nor a status quo. The stay is applicable only to those companies who approached court regarding specific drugs. If a company that is manufacturing the same recombination drug hasn't got stay then we recall the drug. The stay for companies is extended on a weekly basis.”
Both Telangana and Andhra Pradesh do not have any real time mechanism to track and trace drugs that are manufactured, distributed and sold in their markets.
Lack of proper IT supported infrastructure is making the job of the Drug Control Administration tedious and it has to depend on manufacturers, distributors and retail pharmacists for information.
During the recent recall of 344 banned recombination drugs, it had become a herculean task for the drug control authorities of both states. AP Drug Control Authority (DCA) is now thinking of developing a software to track and trace drugs based on their batch numbers and brand names, from place manufacture to the point of retail sales.
Director general of AP DCA A. Ravi Shankar said, “When we or any other monitoring agency find any drug that has gone wrong we need to immediately recall them with the help of the batch numbers and name. However, it is an uphill task to track down these drugs. We are now developing a software and a central server that will store details of all drugs. Tracking can be done on real time basis so that it is easy to withdraw the drug from the market quickly.”
Andhra Pradesh DCA officials said have instructions been given to all field officers whenever something goes wrong regarding a drug. “Our staff literally works along with the distributors and makers to trace the defective batch. Now the instructions can be given to specific field officers to recall a drug.”
Many Pharma companies win stay orders
Many pharma companies have obtained stay orders regarding 230 of the 344 banned recombination drugs. The Delhi High Court has granted stay to companies that approached it. Drug control authorities of AP and TS are withdrawing the remaining drugs from the market and also of those companies who didn’t get stay orders.
A drug control administration official said, “The India Drug Manufacturers Association approa-ched the court seeking a stay on the ban on recombination drugs produced by other companies. However, the High Court refused to grant a blanket stay. So it is very complex. There is neither a blanket stay nor a status quo. The stay is applicable only to those companies who approached court regarding specific drugs. If a company that is manufacturing the same recombination drug hasn't got stay then we recall the drug. The stay for companies is extended on a weekly basis.”
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