Bulk Drug Industries-Violation of Restrictions

Ban on Water Polluting Industries

 

 The AP Pollution Control Board (APPCB), considering the pollution problems, the local issues, need to protect the Drinking Water Sources and Water for Agriculture, issued Notification of 14-10-1996, restricting the establishment /expansion of water polluting Industries in four Districts.

 

 This notification is applicable to all Bulk Drugs, Pesticides (Tech), Dyes & Dye Intermediate manufacturing Industries and all types of Water Polluting industries, in all Industrial Estates and Industrial Development Areas and within one KM radius of Industrial areas, in Medak, Ranga Reddy, Mahaboobnagar and Nallagonda districts for two years from 01-01-97.

 

Subsequently, the AP Govt. issued G.O.Ms.No 62 of 28-04-1999 making the ban notification of 14.10.1996, issued by the APPCB permanent, in accordance with the Hon'ble Supreme Court interim orders dated. 12.05.1998 in W.P.N0.1056/90,

 

Violation of Ban Order

 

 But unfortunately the APPCB seemed to have remained a helpless onlooker, while th the Bulk Drug industries of international repute   violated the ban order, particularly around Hyderabad in Medak and R.R. Districts  during the last one and half decades

                                        

 It is reported that many of the Bulk Drug Industries around Hyderabad are producing the Bulk Drugs far in excess of Types,/ Numbers and Quantities permitted  by APPCB prior to 01-01-1997 the effective date of the Ban., Some of them are also reported to have outsourced the production of Bulk Drug Intermediates , which do not seem to require Environmental Clearance of MOEF, GOI 

 

Non Compliance – High-Profit Business

 

 The non-compliance of Pollution Control Rules & Regulations, particularly for the Bulk Drug Units, has become a high-profit business, because of laxity/collusion on the part of the regulating agencies and the political interference. As a result, the Indian Bulk Drug products have become very competitive in the international markets, as the costs of treating the pollutants are avoided through externalizing pollution by passing it on to the society.

 

Seriousness of Pollution Problem

 

The seriousness of the pollution problem from the bulk drug industries at Pattancheru near Hyderabad was highlighted in 2007, by  an environmental scientist of Sweden ,when  he found at PETL the discharge load of Ciprofloxacin, corresponding to approx 45 kg of active ingredient per day. It is likely to raise antibiotic bacterial resistance in the world, making it a Global Concern.   

 

 In addition to Ciprofloxacin, the supposedly treated effluents of PETL had 21 different active pharmaceutical ingredients, used in generics for treatment of hypertension, heart disease, chronic liver ailments, depression, gonorrhea, ulcers and other ailments. It was reported that half of the drugs detected were 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 complaints by the local communities regarding the discharge of untreated and undertreated effluents from PETL and JETL into local water bodies had been cleverly overcome by transferring the so called treated effluents of these CETPS through pipelines into municipal sewers. They ultimately find their way through Amberpet STP into Musi River which is already heavily polluted

 

What is the Way Out?

 

The present production capacities of the Bulk Drug units of about half a dozen Pharmaceutical Companies of international repute in Medak, Ranga Reddy , Nallagonda and Mahaboobnagar districts need to be verified with capacities approved as on 01-01-1997,the effective date of Ban, restring the expansion / establishment  of new capacities

 

 The thorough scrutiny of data regarding purchase / consumption of the input Raw Materials & Solvents, the use of utilities Water, Fuel,& Power, the  payments of Water Cess,& Central Excise Duty and  the Exports & Sales in respect of these units over the last 15 years, would reveal the hard facts and the culprits, if the authorities concerned mean business without fear or favour ?

 

US FDA

 

The Current Good Manufacturing Practice (cGMP) Regulations enforced by the US Food and Drug Administration (FDA). provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities

If a bulk-drug company is not complying with cGMP regulations, any drug it makes is considered "adulterated" under the law.  This kind of adulteration means that the drug was not manufactured under conditions that comply with cGMP.  It does not mean that there is necessarily something wrong with the drug.

 Even if the drugs are not defective, FDA can bring a seizure or injunction case in court to address cGMP violations.   When FDA brings an injunction case, FDA asks the court to order a company to stop violating cGMPs.  Both seizure and injunction cases often lead to court orders that require companies to take many steps to correct cGMP violations. The FDA can also bring criminal cases because of cGMP violations, seeking fines and jail time.

 Is the US, FDA not aware of cGMP violations. by these select Indian Bulk Drug manufacturing Companies, the largest suppliers of Bulk Drugs to USA ?

Conclusion

These Bulk Drug Industries contaminating the Air, the Water and the Soil, in violation of Rules and Regulations, are committing Environmental Crimes that often damage the community more seriously than the Criminal Offence of the conventional kind..

 

The Bulk Drug Industries, setting aside their "Corporate Social Responsibility" are willing to take the risk to the bitter end, until it is no longer possible to conceal & fool around and it economically hurts. Therefore, the facts of the Crime have to be revealed, the wounds inflicted have to be shown, and the culprits have to be named and penalized, so that it hurts them economically and socially.

 

 If they cannot be disciplined even then, they will have to be penalized like the hard core criminals Can we expect this to happen in our present system of Governance?