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Nandita Vijay, Bengaluru August 16 , 2022
The Karnataka State Registered Pharmacists Organisation (KSRPO) has raised a slew of objections and suggestions to the draft of the New Drugs, Medical Devices and Cosmetics Bill, 2022. This includes substituting the word ‘drug’ with ‘medicine’ among others.

Stating that in Section 1 Page No 2 of the draft Act, the word ‘drug’ in the present day parlance denotes intoxicating, illegal and banned substances, used clandestinely. Since this enactment is in no way related to such drugs this word, wherever occurs in the entire Act, needs to be changed to ‘medicines,’ suggested KSRPO president Ashokswamy Heroor in his communication to the Union government.

In Section 3, Page No 2 he has called for the inclusion of a definition for ‘Agent for the Distribution’. Referring to Sections 42, 44 (3), 44 (4), 70, he indicated about a specific class of wholesale dealers, identified as ‘Agent for the Distribution’.

Here Heroor said that they are definitely different from other wholesalers, distributors or C&F agents. They have been treated on par with their principal manufacturers or importers, even though they are basically dealers and requires a precise definition has to be included in the Act. They may be granted a separate wholesale license, to be termed as ‘Agent License’ and permitted to distribute only the products of their principal manufacturer or importer. If they deal in other products, they may be treated as unlicensed dealers. But should strictly not allow to distribute to doctors, hospitals, dispensaries, research/teaching Institutes, government departments or charitable/private Institutes, except where the purchase is through competitive tender bidding.

Referring to the Sections 18 (f) and 37 (f) on Pages No 12 and 18 on the definition of Spurious drug, he said that is  observed that in order to avoid a drug being classified as ‘spurious’, some manufacturers incorporate a very small percentage of the active pharmaceutical ingredients in the otherwise spurious drugs. This will result in softer punishment if detected. Our suggestion is that at the end of the Section 18 (f) and Sec. 37 (f), after the words ‘ingredients’, these words may be added: or contains less than 75% of the label claims of at least one active pharmaceutical ingredient."

On Section 41 (2); Page 20, referring to the prohibition of online sales and app assisted sales, he said that while it proposes to legalise the online pharmacy, this mode of sales has been criticised as it results in serious consequences. It should not be introduced in this profession. Therefore our suggestion is that this needs to be omitted.

Commenting on the rationalisation of penalties for prosecution and for false complaint, Heroor said there needs to a same amount levy. The proposed penalty in respect of erring officers is less than Rs. 30,000 but the penalty for false complaint is more than Rs. 50,000, though both these offences are of the same severity.  Here the Association suggests that since both the offences are similar, the penalty may also be made same for both of the offences.

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