One of the most prominent and notorious pharmaceutical industrial clusters of the country, is around Pattancheru west of Hyderabad City. Over the past 2 to 3 decades, a growing chain of industrial estates has turned about 50 KM stretch of the countryside into an ecological sacrifice zone. In this stretch near Hyderabad, almost 40 percent of the country's bulk pharmaceuticals are produced and a large proportion of them for export. While the Bulk Drug Industry flourishes from exports, the people in the affected villages perish, from toxic effluents discharged from a myriad of drug units, into surface and ground water sources.
Back Ground of Bulk Drug Industry
The Citizens Group approached Hon'ble Supreme Court to get relief from unabated pollution of Surface and Ground water sources and the Soil by untreated and/or under treated effluents, from Bulk Drug Industry, in violation of Water Act and Environment Protection Act. The Supreme Court in W.P. 1056/90 directed that the industry should segregate degradable and non-degradable effluents for treatment by the industry before they are discharged or disposed for further treatment. But unfortunately, the directive is neither observed by the industry nor enforced effectively by the Regulating Agency
The AP Government issued G.O.Ms.No 62 of 28-04-1999, restricting the establishment /expansion of water polluting Industries- Bulk Drugs, Pesticides (Tech) etc.-in industrial estates of four districts around Hyderabad, in compliance with the Supreme Court interim orders in W.P.No.1056/90, This order was issued primarily taking into consideration, the alarming levels of pollution and long lasting damage done to surface and ground water sources in the immediate neighborhood of Hyderabad Metropolitan Area .
But unfortunately, the Bulk Drug industry continues to indulge in production of the Drugs far in excess of the permitted quantities and / or unconsented (illegal) products leading to heavy pollution of Air, Water and Soil in the areas. As a result MOEF notified Pattancheru-Bollaram Industrial Cluster as one of the critically polluted areas in the country
Pattancheru Hell on Earth!
A survey undertaken by Greenpeace India in 2004 is reported to have found high rates of illnesses in the affected villages where water is shared with bulk drug units. Clinically confirmed cancer was found to be 11 times higher in the study group. Respiratory diseases affected one in every 20 persons. Heart diseases were 16 times higher. Congenital malformations and chromosomal abnormalities were 3.93 times higher. Disorders of blood and blood forming organs were 2.9 times higher and that of skin and sub- cutaneous tissues 2.67 times more. The study was conducted in the villages of Bonthapally, Chitkul, Digwal, Gaddapotharamu, Khazipalle, Kistareddypet, Pasha Mailaram, Pocharam and Sultanpur in Pattancheru, Jinnaram and Kohir Mandals.
Thousands of acres of formerly good farmland around Pattancheru lie uncultivated during the dry season because groundwater has become unfit for irrigation. The court committee visited 40 "pollution potential" companies in the industrial estates. Of those, 30 were producing drugs or drug ingredients, and only five were complying fully with lenient pollution laws. The court committee sampled 48 wells in the area and found 81 percent polluted beyond an international standard for irrigation water. In accordance with court orders, bulk drug companies are paying to have safe water piped into affected villages for drinking and cooking. But the polluted water is still used for other purposes in the home and on the farm. Pollutant concentrations in streams and lakes range from 12 to 100 times as high as those in an unpolluted lake just outside the contaminated zone, according to the 2004 report of a committee appointed by the AP High Court.
Despite repeated crackdowns by APPCB, some Bulk Drug Units continue to pollute the Pattancheru area's Air with sulfurous mercaptan compounds that smell like rotten fish ironically, during the production of stomach antacids. Pattancheru area, where normally only the total quantity of pollutants- BOD, COD, TDS etc.- is tracked, there's almost no information about specific toxic compounds. That is serious, because some of the drug industry's solvents, byproducts and ingredients can harm people even at low concentrations.
Cutting Corners to be Competitive
Many of the units of international repute in the area produce "Bulk Drugs", technically known as "active pharmaceutical ingredients" - raw materials for making Pills, Capsules, etc. As international Bulk-Drug market competition is fierce, the corner-cutting on Waste Treatment is rampant, by resorting to discharge of untreated and/or under treated effluents into surface water bodies, streams, drains, municipal sewers etc. The non- compliance of Rules and Regulations has become a HighProfit Business, paving the road to the profit of the Indian Bulk Drug industry, with ecological and human costs & tragedy passed on to the society. The Regulating agencies and the State have become passive onlookers; to this reprehensible conduct of the industry, in violation of Article 48-A of The Constitution.
. When it comes to the cost of patented prescription drugs in United States, the sky's the limit. But in global bulk drug market, low cost is the name of the game, and India's People are subsidizing. Over medicated patients in America are inflating the demand for drugs having serious side effects in India. The countries importing Indian Bulk Drugs, who have commitment for Good Manufacturing Practices, Ecology, Human Rights etc., may like to consider additional "Warnings" on Drugs made out of imported Bulk Drugs from India.
"Side effects, including drowsiness, skin rashes, gastrointestinal distress, neurological disorders, cardiovascular problems and/or cancer, may be encountered by those living near the site of manufacture of this drug."
"Consumption of this antacid may induce headache, coughing and/or nausea downwind from where it was produced."
"Some patients may experience sharp pangs of remorse when they learn more about the conditions under which this medication was produced."
Toxicity of Effluents from Bulk Drug Units
It was known for long that Pattancheru area was drenched in pollution by chemicals, solvents, and other, unidentified stuff. But no one suspected that it was an open-air laboratory for breeding antibiotic-resistant bacteria, though the area had been suffering from awful water quality and widespread health complaints for years. The seriousness of the pollution problem from bulk drug industries at Pattancheru was highlighted in 2007, by Joakim Larsson, an environmental scientist at the University of Gothenburg in Sweden.
When he analyzed vials of so called treated wastewater taken from Common Effluent Treatment Plant Pattancheru (PETL), he found the discharge load of Ciprofloxacin, corresponding to approx. 45 kg of active ingredient per day at the highest concentrations ever recorded in effluents. This is equivalent to the total amount of Ciprofloxacin consumed in Sweden (population 9 Million) over an average 5 day period.
And it wasn't just ciprofloxacin being detected. The supposedly treated wastewater of PETL has 21 different active pharmaceutical ingredients, used in generics for treatment of Hypertension, Heart Disease, Chronic Liver ailments, Depression, Gonorrhea, Ulcers and other ailments. Half of the drugs measured in waste waters are at the highest levels of pharmaceuticals ever detected in the environment. In economical terms, if the equivalent amount of the 11 most abundant active substances released by PETL during 24 hrs. were to be purchased as final products in a Swedish pharmacy; they would cost over 100,000 British Pounds.
The high value of final product compared to much lower production cost of bulk-drugs, which is reported to be around 15% of the cost in developed countries, appears to be the reason for cutting corners. In the absence of deterrent penal action in the country and pressure from the importing countries, why should Indian Bulk-Drug industry minimize the release of certain drugs into waste waters, involving substantial investments? In the process, Hyderabad City Population is being "drugged' through various water sources, with record levels of remedies for the maladies they don't have (yet), including ulcers, high blood pressure, and allergies
AP Bulk Drug Industry- Utter Disregard to Rule of Law!
While the Industry Associations are advocating the Corporate Commitment (Responsibility) to Society, the AP Bulk-Drug Industry seem to be indulging in manufacture of 'unconsented' (illegal) products, in utter contempt to Society by claiming that their pollution load has not increased despite increase in production quantity and introduction of new products, by ensuring " Zero Discharge' which is nothing but a myth.
In the light of huge export potential of Bulk Drugs, the State Government, unmindful of serious consequences, acceded to the request of the Bulk Dug Industry for lifting the Ban on Expansion of Bulk Drug Units, imposed as per the directive of Hon'ble Supreme Court