To address the issues faced by the trade associations in the state, the Maharashtra government recently constituted a committee consisting of officials from the Maharashtra Food and Drug Administration (Maha FDA) and representatives from the pharma trade associations. The aim of the committee is to initiate active dialogue between the regulatory body and the trade associations on crucial issues affecting the functioning and implementation of the drugs and cosmetics (D&C) Act across the state.

The idea of setting up this committee was initiated by the Minister of State, Satej Patil to basically encourage better understanding between the trade associations and FDA by providing them with a platform to directly address their issues with each other. The committee which was set up last month is chaired by K B Shende, joint commissioner drugs, Maha FDA, who heads a seven member team consisting of three FDA officials and four active members from different trade associations.

Apart from addressing other larger issues, the main focus of the body is to analyse and evaluate the response of the trade associations and understand their views on rule 64, 65 and rule 66 of the D&C Act. During their first meeting special focus was given on addressing trade associations demand to synchronise the margins of the distributors’ and retailers’ under the Drug Price Control Order (DPCO).

The committee also deliberated on various issues faced by the associations in following the provisions enlisted in para 15, 18 of the DPCO. Along with detailed debate on modifying para 19 of the Order which deals with provisions dealing to manufacturers selling any formulation to a vendor. The committee has been directed by the state government to get all the stakeholders view on the above mentioned rules latest by mid July so that is can be submitted to the government for further proceedings.

According to Shende, “We have been directed to take opinion and suggestions from the retailers, wholesalers, druggists and chemists in the state on this particular issue which if, feasible will be considered in our recommendation to the government. To achieve our goal we will be having more such discussions and deliberations with them in the coming days, so that we can soon get into a consensus on this issue and submit the report at the latest.”

He further informed that the this forum through this committee FDA will be able to communicate more effectively with the stakeholders on their expectations and requirements from the industry when its comes to compliance of the rules and regulations as provided in the Act.

The committee is soon expected to organise its second meeting in the coming days so that concrete decisions can be taken on this matter. Once the report is prepared it will be submitted to the state government for its review. After the initial review this report along with their comments will be further send as a recommendation by the state government to the central government for their approval.

If the central government approves the recommendation suggested by the committee, required changes will be made accordingly by either amending, reviewing or omitting the concerned clause or provisions from the Act.