The state of Andhra Pradesh (AP) has around 200 bulk drug and 530 formulation units including SMEs in the organised and unorganised sectors. About 30 per cent of the medicines exported from India to the US are from AP and recognising the importance, US FDA opened offices in New Delhi and Mumbai.
According to Captain VVSK Sastry, Assistant Secretary General, Bulk Drug Manufacturers Association (BDMA), Andhra Pradesh (AP), the bulk drug industry is expected to grow between 11 to 13 per cent in 2013-14. The state is home to several leading pharmaceutical companies like Dr Reddy’s Laboratories (DRL), Aurobindo Pharma, Hetero Laboratories, Mylan Laboratories, Divis Laboratories, GVK Bio Science, Natco Laboratories, MSN Laboratotories, Andhra Organics, Virchow Laboratories etc.
Ban notification
All active pharmaceutical ingredient (API) majors in AP have demonstrated the use of available and proven technologies for management of environmental factors. Today, Hyderabad is recognised globally as a ‘pharma hub’ along with its supremacy in the software industry as well.
However, the bulk drug manufacturing sector in the region is in a quandary, despite its global recognition and its efforts in making exemplary improvements in environment management in general and waste water management in particular.
An industry expert, who did not wished to be named, comments, “Forget about growth, even survival itself is a big question mark.” This situation is due to the ban imposed in 1996 by a Government notification on certain categories of industries that include bulk drug manufacturing units. Till date, the worst affected sector is the bulk drug manufacturing sector as these units constitute more than 90 per cent of the total industrial establishments that come under the purview of the banned notification.
 “Innovations and advancements in process technologies and waste treatment technologies have made bulk drug manufacturing processes more clean and environment friendly.”VVSK Sastry Asst. Secretary General, Bulk Drug Manufacturers Association |
Sastry informs, “The issue of the ban notification was a result of a short term and immediate measure proposed in a Joint Action Plan by Andhra Pradesh Pollution Control Board (APPCB) and Central Pollution Control Board (CPCB) for a PIL filed in the Supreme Court of India by the Indian Council for Enviro Legal Action, a NGO. The Joint Action Plan proposed by APPCB and CPCB contains short, medium and long-term plans. It is noteworthy that in its orders dated May 12, 1998, the Supreme Court, in fact, ordered to declare the temporary ban, on its expiry, as permanent for new industries only. But, subsequently, the temporary ban issued initially was made a blanket permanent ban for all identified categories of existing and new units. Industry associations report that if one looks into the rationale under which the ban was imposed almost two decades ago, it is clear that the allegation at that point of time is mainly discharge of industrial waste waters, consequent damage of crops and endangering biota. Given the circumstances and technological limitations of industry, imposition of a restriction was justified at that time but as said, it was 16 years back.”
He further said, “Times have now changed. Innovations and advancements in process technologies and waste treatment technologies have made it possible for bulk drug manufacturing processes to be clean and environment friendly. In fact, the embracing of newer technologies by bulk drug manufacturing sector is not solely by choice but due to a compulsion to compete and be sustainable in the international market; to meet expectations of environment, health and safety competency standards of global customers and most importantly to make the manufacturing processes viable.”
Learning curve
Effluent treatment plants and solid waste management plants, using the latest technology, have been established in AP for disposal of waste, in a scientific manner, under the supervision of State Pollution Control Board. API units located only in the four districts of AP, viz., Hyderabad, Rangareddy, Medak and Mahaboobnagar are faced with a restriction imposed by the Government of AP on certain categories of industries which include API units.
“However, in the recent past, there were two independent studies and recommendations by two expert technical committees constituted by Appellate Authority, AP and APPCB and improvements were made by API companies in these four districts. These committees recommended the relaxation of the restriction imposed on API companies. The API companies are hopeful of a positive and favourable decision by the Government of Andhra Pradesh in this regard,” reveals Sastry.
Subsequent to imposing the restriction in 1997 on expansion and modernisation of industries in four districts, the Government of AP ensured that the action plan submitted by APPCB and CPCB to the Supreme Court was implemented in totality with respect to air, water and hazardous waste management with establishment of common effluent treatment plants (CETPS) and common secured landfill facilities (TSDF). The management of organic wastes generated in API companies has gone to a superior level due to the utilisation of these wastes as ‘auxiliary fuel’ by cement units located in different parts of the state. This has resulted in MoEF delisting the Patancheru-Bollarum industrial cluster from the critically polluted areas.
Sastry predicts, “The Government of AP is likely to consider the reports and recommendations of the two expert committees constituted in 2012 to look into the improvements made by API companies in environmental management and the industry is hopeful of a favourable decision in this regard.”
Challenges faced by pharma companies
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State initiatives
Today, AP-based pharma companies manufacture the maximum number of APIs and are currently facing waste disposal related issues, which is causing harm to the environment to a large extent. Sastry agrees with the fact that the maximum number of APIs are produced by AP-based companies but avers that the state also has a proper waste management system in place.
He replies, “Pharma companies in AP are manufacturing the maximum number of APIs. It is a misrepresentation that the companies are currently facing waste disposal related issues. Technically, AP is leading the way in industrial waste management. The state topped the Environmental Performance Index (EPI) during 2012 for adopting best green practices to maintain quality of air, water and forest cover.”
 “The state government has put forth more stringent laws and also provided common waste treatment plants in few industrial clusters.”Dr Vilas Dahanukar Vice-President, Global Process R&D Head, Dr Reddy’s |
“The state government has put forth more stringent laws and also provided common waste treatment plants in few industrial clusters. But, the implementation of the law in spirit is lacking. A few months ago, some polluting units were closed down but they were again given permission to operate. As usual, the government rules, regulations and schemes are sound on paper put lack proper implementation due to inadequate will, vision and resources,” informs Dr Vilas Dahanukar, Vice-President, Global Process R&D Head, DRL.
Remedial measures
Increasing competition from China, pricing pressures and increasing environmental regulations are some of the challenges faced by AP pharma companies. Dahanukar feels, “The companies need to change their mindset and think of long-term solutions. Innovation based on green chemistry and green engineering principles is one way of addressing these issues.”
Shastry says, “The investment on environment management infrastructure by API manufacturing companies in AP during 2008 – 2012 is estimated at Rs 250 crores against an estimated investment of Rs 350 crores upto 2008.”
Water treatment plants, an important part of pharma facility, while being set up requires huge investments. Dahanukar suggests, “There should be some incentives given to smaller industries to reduce waste generation and promote treatment of waste in the right manner. A well maintained industrial effluent treatment plant should be set up to serve the needs of smaller companies. Smaller companies should pay for the service provided.”
“It is really a matter of concern that small companies cannot afford to invest in high strength waste water treatment. However, common effluent treatment established for low strength waste water are operating for many years. It is a requirement of significant investment on waste water treatment to comply with the regulations in vogue. However, BDMA, with support from APPCB and Government of AP, are trying to establish common waste water treatment facilities for high strength in different industrial estates,” informs Shastry.
Shastry emphasises, “All major API companies have invested heavily in such systems, viz., strippers, multi-effect evaporators, bio-ETPs, reverse osmosis systems and achieved zero liquid discharge or zero process liquid discharge. As on date, API manufacturing companies are able to treat entire waste water generated from manufacturing of products and recycle the treated waste water. The solid waste derived out of such treatment is also disposed off to scientifically designed TSD facilities. That is how, the process waste water, in any form, is controlled from being in contact with ground or surface water. Hence, the possibility of hazardous chemicals entering into surface or ground water is remote.”
If industrial waste is not treated and disposed in the right manner, it is bound to harm the environment and population. “First of all, no untreated industrial waste should be discharged in any water bodies. Organic waste is incinerated in cement manufacturing plants as a fuel and the aqueous waste needs to undergo chemical and biological treatment. All aqueous waste after treatment is recycled. Any potent drugs manufactured are neutralised at the source. Innovation based on green chemistry and green engineering principles will help in addressing these issues. The chemicals and pharma manufacturers should form a local chapter to share best practices and adopt green technologies. The government’s support for such an initiative is required. In a way, the environmental challenge can offer a great opportunity to develop a sustainable future,” adds Dahanukar
Given these comments, it is evident that major players in the API industry in AP are hopeful of overcoming environmental issues; technical, administrative or regulatory; within the next six months or a year.
