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c. During the investigation by the DG, most of the companies had stated that the purpose of payment of PIS charges was to ensure widespread dissemination of information and to create awareness about the new drugs launched by these companies. Such payment in respect of PIS charges ensured deemed compliance of law and enabled advertisement and circulation of product information to all the retailers at a very nominal cost. The same was stressed upon by Mankind Pharma Limited, Koye Pharmaceutical Private Limited, Unichem Laboratories Limited, Macleods Pharmaceuticals Limited, Intas Pharmaceuticals Limited and Alkem Laboratories Limited;
d. Payment of PIS charges was not mandatory. Many pharmaceutical companies had sold medicines in Jalgaon District without payment of PIS charges which showed that PIS charges were voluntary. In support of its submissions, the OP has relied upon the statements of representatives of pharmaceutical companies including Mankind Pharma Limited, Koye Pharmaceutical Private Limited, Unichem Laboratories Limited, etc. to prove that payment of PIS charges was not mandatory. Replies of Organisation of Pharmaceutical Producers of India (OPPI) and Indian Drug Manufacturers Association (IDMA) were also referred to, to submit that there had been no instance when pharmaceutical companies, being members of the association faced difficulty while launching new drugs. Further, there was no instance of refusal of publishing of product details after collecting PIS charges, which was evident from the statements of pharmaceutical companies recorded during the course of investigation;

34. With the aforesaid background, the Commission proceeds to determine the issues framed above.

Issue 1: Whether collection of PIS charges by JDMDA/OP from pharmaceutical companies was mandatory/compulsory and thus in contravention of the provisions of Section 3 of the Act?

35. In order to ascertain the need and purpose for which PIS charges were paid by pharmaceutical companies before launch of products in Jalgaon District, the DG considered replies of certain pharmaceutical companies namely Unichem Laboratories Limited, Macleods Pharmaceuticals Limited, Wanbury Limited, Intas Pharmaceuticals Limited, Cerovene Healthcare Private Limited, Cadila Pharmaceuticals Limited, Alkem Laboratories, M/s Unifab Pharmaceuticals, Mankind Pharma Limited, etc.

37. The Commission perused the replies/statements of the following pharmaceutical companies recorded before the DG, the relevant excerpts of which are reproduced below:

a. Mankind Pharma Limited, in its reply dated 12.05.2016, to the DG's notice, stated as under:
"....The "information about new drugs" is published in the Jalgaon Chemist Samachar for wider dissemination/publicity of information with respect to new drugs for the benefit of trade and distribution channel of MPL."