Tuesday, December 11, 2018

Final regulations on e pharmacy likely by December-end, says DCGI


In September, the Union health ministry came out with draft rules on the sale of drugs by e pharmacies. 
The union government is expected to come out with final regulations for the companies selling medicines online by the end of this month, Drugs Controller General of India Eswara Reddy said on Friday. The aim is to regulate the sale of medicines through e-pharmacy across the country and provide patients access to genuine drugs from authentic portals only. He said they already have examined the comments of stakeholders on draft regulations, which were released in September. “The biggest hurdle for the growth of online pharmacy is that we do not have any regulations. By the end of this month, the government is going to finalise the regulations,” he said here at the Global Venture Summit. Currently, there are no regulations for such entities.
Regulations will help investors understand the risk and benefits of investing in the sector, he added. Currently, the market size of the retail sale of medicines is about Rs 1.2 lakh crore.
The market size of online sale of medicines is about Rs 3,500 crore, and is expected to increase to Rs 25,000 crore in the next 3-4 years, he said. The habit-forming drugs (narcotic and psychotropic substances) would not be allowed to sell through this platform, he added. In September, the Union health ministry came out with draft rules on the sale of drugs by e-pharmacies. According to the draft rules on ‘sale of drugs by e-pharmacy’, no person will be allowed to distribute or sell, stock, exhibit or offer for sale of drugs through the e-pharmacy portal unless registered.
“Any person who intends to conduct the business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority in Form 18AA through the online portal of the Central government,” the draft notification had said.
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