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DCGI should lay down specific norms for online pharmacies or frame rules with no delay: Dr BR Jagashetty

Nandita Vijay, Bengaluru
Monday, June 27, 2016, 08:00 Hrs  [IST]

Drugs Controller General of India (DCGI) needs to formulate a set of dedicated rules for online pharmacy as the issue is turning murkier by the day. This is because the current D&C Act and Rules do provide a guidance and the regulatory authority has an option to re-examine the same and permit online pharmacy business model with any specified restrictions, said Dr BR Jagashetty, former national adviser (drugs control) to Union health ministry and former Karnataka Drugs Controller.

The present D&C Act and Rules clearly indicate that drugs specially Schedule H, H1 and X are to be sold by a licensed outlet  under supervision of an approved pharmacist present to vend the same via doctor’s prescription. In such a case, there should be no problem for online pharmacy players to operate in the country, he added.

For instance, Rule 65 (11) (c) of D&C Rules refers to endorsement  on the prescription for having dispensed a drug. Rule 65 (10) mentions about the prescription’s model which should be in writing by RMP with his signature and date. It does not mention specifically that a prescription should be in an original format. Therefore, one may argue, even a scanned or photo-copied version is acceptable. Therefore, it is crucial for the drug regulator to now indicate in a lucid manner the key aspects needed to pursue online sales by any licensed dealer.  

Coming to the delivery of medicines and medical devices like blood glucose and blood pressure monitors among others online, then these players need to adhere to the good distribution practices’ (GDP) guidelines issued in October 2012 by CDSCO.

Coming to Rule 61 (1), (2), (3) of D&C Rules, 1945 which provide the Forms of licenses to sell drugs, it mentions, “ A license to sell, stock, exhibit or distribute drugs…………...,” accordingly permission to do business by way of retail are issued in license in Form 20 & 21. But the Act or Rules do not define the mode of sale. Hence online pharmacy can definitely be operational, pointed out Dr Jagashetty.

In an age where e-commerce business is on the rise and online mode of purchase is all pervasive, buying pharmacy related products is already on. When online sales operations are seized blindly without verifying whether they are undertaking the sales as per prevailing provisions of D&C Act and Rules with proper license etc, it is now causing confusion and chaos.

The pharmacy business model is undergoing a sea-change to provide the convenience for customers who are patients in the comfort of their homes, said Dr Jagashetty adding it is high time for drug regulatory authority to either release specific norms or frame required rules with no further delay in the interest of patient’s safety and convenience.

 

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