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DCGI should lay down specific norms for online pharmacies or frame rules with no delay: Dr BR Jagashetty
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Nandita Vijay, Bengaluru
June 28 , 2016
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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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