Bulk drug manufacturing in India to go green; Eco-norms will cover more small scale API producers

Pharmaceutical manufacturing, especially in the more chemical effluents creating bulk drug production plants in India may become environment-friendly soon.

Pharmaceutical manufacturing facilities in India are already following certain environmental hazard limiting norms. However, even more active pharmaceutical ingredients (APIs) or bulk drug making units in the small scale sector would be brought under the purview of new environment hazard limiting norms soon.

A Task Force set up by the Department of Pharmaceuticals, under the Union ministry for chemicals and fertilizer, on the environmental hazards in pharma sector has recommended inclusion of more small and medium enterprises (SMEs) manufacturing units for environmental performance improvement as part of the proposed action plan.

75 per cent of the pharma manufacturing industries should be from small and medium enterprises for the activities related to environmental performance improvement, hazard/emergency management, ecoprofit etc, according to the action plan from the Task Force plan for the period upto 2012-13.

In Indian API or bulk drugs manufacturing sector, majority of producers belong to either small or medium segment.

Initially, the Task Force would focus on the western state of Maharashtra which is home for a good chunk of India’s drug manufacturing facilities for two years. The pilot phase will also cover bulk drug manufacturing units in Himachal Pradesh (Baddi Nala area), Andhra Pradesh the so-called bulk drug capital of India, Gujarat and Tamil Nadu.

Other states having bulk drug manufacturing operations such as Punjab, Madhya Pradesh, Haryana and West Bengal will come in the second phase. The recently formed state of Uttaranchal may not be included as there are not many bulk drug industries.

No fee would be charged to industries in the initial phase as pilot efforts have to be tested  The schemes may be made available in the market in a later stage based on the success of the pilot efforts,and the industries may be asked to pay for the services, eports said.

The Task Force  has also recommmended clean manufacturing processes including CDM (clean development mechanisms), improvement of environment performances, hazard management in individual industries, transformation of existing parks into eco industrial parks based on sustainable industrial development models integrating environment, hazard, energy and climate issues, planning of the upcoming industrial parks on sustainable development, and development of the national action plan on disaster management in the pharma industry.

The environmental performance improvement in pharmaceutical industries including safety and occupational hazard management, development of onsite/offsite emergency plans and cleaner production will be demonstrated through the concepts of ecoprofit, emergency/hazard management, energy efficiency, CDM, cleaner production techniques etc . leading to improved manufacturing processes, improved environmental quality and reduced risks/impacts on environment, reports said.

Environmental interventions in the pharmaceutical manufacturing sector will be limited to bulk drug units and not to formulation manufacturing units as they do not have similar complexity of problems