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A recent report of a high-level expert committee appointed by the Andhra Pradesh Pollution Control Board has sought to differentiate bulk drug units in terms of those who are equipped to meet compliance norms and those who are not.
This apparently simple suggestion comes against the backdrop of a 15-year-old ban on capacity expansion and also on setting up new units in four districts around Hyderabad city that has made the 155-odd units practically indistinguishable in the eyes of the law.
Under ban orders, compliance by a unit was being determined on the basis of whether it had stuck to the pollution load (granted in 1996) at the pre-treatment level and not on the basis of disposal or discharge of treated effluents, which would have led to actual pollution compliance.
But, this method of measuring pollution loads became legally untenable in October last year when the Appellate Tribunal, while suspending the closure orders issued against some of the bulk drug units, said it was only the levels of effluents after treatment that had to be taken into consideration.
In practice, the board could neither contain the production capacities of these units at the pre-ban level nor it could stop the sporadic violations, the worst kind of which has been dumping the untreated effluents by some unscrupulous companies, according to a senior official of the environment department.
A few evidences of such dumping were produced by local public representatives at a meeting recently held by the Assembly speaker.
The production of bulk drugs or the active pharmaceutical ingredients (APIs) as they are usually referred to is the backbone of the over Rs 45,000-crore pharmaceutical industry in Andhra Pradesh. All the major formulations companies like Dr Reddy's Laboratories, Aurobindo Pharma and Mylan have their API facilities. Companies like Divi's Laboratories, Granules India and Hetero Drugs heavily make APIs in addition to formulations.
A significant portion of AP’s pharma business comes from bulk drug operations, which stands at Rs 19,258 crore, while the formulations comes on top with Rs 25,998 crore in size, according to the Bulk Drug Manufacturers Association (BDMA).
Though formulations units are out of the purview of the ban orders, the symbiotic relationship between the two had made it tough for the hassle-free growth of the whole sector due to the ban. Industry representatives say the chemical concentration data compiled at common effluent treatment plants showed a lot of progress compared to what it was in the last decade in addition to the individual efforts made by big companies.
According to S Radha Krishna Murthy, executive director of BDMA, major pharmaceutical companies based in Hyderabad had turned their API plants into zero liquid discharge (ZLD) facilities with systems like strippers and multieffective evaporators and some had set up the partial ZLDs with only waste water generated from non-chemical use being sent to common effluent treatment plants.
Request to modify ban orders
While explaining the steps taken to reduce the pollution loads by the companies, the industry body requested the government to “allow the expansion of existing bulk drug and its intermediate manufacturing units having zero liquid discharge facilities and industries who could send less contaminated non process waste water such as domestic, cooling tower and boiler blow down to common effluent treatment plants (CETPs).”
“The very fact that 49 out of the 169 US FDA approved facilities in India are located only in Andhra Pradesh reflect the higher regulatory compliance practices adopted by these companies,” Murthy said.
The committee, in its report, which was reviewed by this reporter, said the ban notification and its subsequent extension were issued in view of lack of proper effluent treatment facilities by industries, inadequate performance of CETPs, absence of hazard waste treatment, storage and disposal facilities and discharge of untreated/partly treated effluent to the water bodies or land.