The bulk drug manufacturers in Andhra Pradesh have urged the state government not to insist for new Environmental Clearance (EC) from the Union Ministry of Environment & Forest while putting up CFE applications with the pollution control board for change of product mix for bulk drug manufacturing.

Bulk Drug Manufacturers Association (BDMA) president M Narayana Reddy said that this has been a major issue before the bulk drug manufacturers in the state for a long time as the Andhra Pradesh Pollution Control Board (APPCB) always insists for fresh EC from the Union Environment ministry for change of product mix every time. A BDMA delegation met the state minister for forests and environment Ramachandra Reddy recently and sought his intervention in the matter for a lasting solution to the lingering issue.

The bulk drug industry is highly dynamic, where the manufacturing of products keeps changing with time. Therefore it is absolutely necessary for units to change their products to keep pace with market dynamics. But, the clause of fresh EC for change of product mix every time is coming as stumbling block, the BDMA said.

When the central government gives approval (CFE) they do not give the consent only with specific reference to particular bulk drug but they give consent for bulk drug as a category of similar or a group of products, which covers any type of bulk drug. However, whenever there is a change in the product either as a substitute or addition, APPCB insists for EC from MoEF for such change. S.O.No. 60(E) para-2 of EIA Notification dated 27.01.1994 read with item No.8 of Schedule-I and also Notification GSR No. 1037 (E) dated 05.12.1989 of Pollution Control Act & Rules 1986 and its rules, "Bulk Drug" is categorized as a separate broad head, the BDMA argued.

Giving example, the BDMA said that if a unit is manufacturing Ciprofloxacin, a bulk drug and if it wants to stop it and produce another bulk drug say norfloxacin it cannot do so without getting fresh EC from central government as per APPCB's contention. This is anomalous because both Ciprofloxacin and norfloxacin belong to bulk drug category, the BDMA said.