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Compliance Complexes in The Indian Pharmaceutical Industry

Compliance Complexes in The Indian Pharmaceutical Industry
INTRODUCTION

Indian Pharmaceutical Industry is one of the fastest growing industries and has emerged as an international centre for contract research and manufacturing services. The main growth factors are international standard quality and low costs. With all the development in the industry, India is on the way to becoming the biggest producer of drugs in the world.

Since every coin has two sides, so has the rapidly developing pharmaceutical industry. Since pharmaceutical industry is largely involved in manufacturing and production of medicines, it has resulted into massive generation of Bio Medical wastes as well.

WHAT ARE THE MAJOR CHALLENGES FACED BY THE INDUSTRY?

The waste management system in India is very diverse in nature the waste are categorized into e-waste,Bio Medical waste, Municipal Solid waste, Plastic waste, Hazardous waste and radioactive waste. Each category of waste is having a different method of disposal prescribed under different statutes hence making it more difficult and complex to determine the right method for disposal. Bio Medical waste being one of the major waste generated by pharmaceutical industry, it should be properly channelized to a common Bio Medical WasteTreatment Facility or shall be disposed of in accordance with the Rules.

WHAT IS BIO MEDICAL WASTE?

‘Bio-medical Waste’ as defined in Bio- Medical Waste (Management and Handling) Rules,1998 is “any waste, which is generated during the diagnosis, treatment or immunization of human beings or animals or in research activities pertaining thereto or in the production or testing of biological, and including categories mentioned in Schedule I.”

PROCESS IN STPS AND ETPS

A ‘Sewage Treatment Plant’ is a plant which treats wastewater from either municipality i.e. the water used in kitchens and in households for domestic purposes or industry waste having soluble organic impurities or mix of both waste water sources. While in a ‘Effluent treatment plant’. In a ‘Effluent treatment plant’ the ‘Trade Effluents’ are treated i.e. any liquid waste (effluent),other than surface water and domestic sewage; e.g. fats, oils, greases, chemicals, detergents,heavy metal rinses, solids, food wastes. In general terms it treats the type of wastes which if left untreated pose a greater harm to the environment.

The process carried on in such plants is a mixture of aerobic and anaerobic processes in order to obtain optimum results. Aerobic, as the title suggests, means in the presence of air (oxygen);while anaerobic means in the absence of air (oxygen). These two terms are directly related to the type of bacteria or microorganisms that are involved in the degradation of organic impurities in a given wastewater and the operating conditions of the bioreactor. Therefore, aerobic treatment processes take place in the presence of air and utilize those microorganisms (also called aerobes),which use molecular/free oxygen to assimilate organic impurities i.e. convert them in to carbondioxide, water and biomass. The anaerobic treatment processes, on other hand take place in theabsence of air (and thus molecular/free oxygen) by those microorganisms (also called anaerobes)which do not require air (molecular/free oxygen) to assimilate organic impurities. The final products of organic assimilation in anaerobic treatment are methane and carbon dioxide gas and biomass.

In an STP, the process is less time consuming then that in an ETP as the molecules of the waste treated in a STP are easier to break from those treated in an ETP. The water discharged after treatment in an STP can be used for gardening and watering plants whereas the water discharged from an ETP still has to be disposed off in landfills and cannot be used for any other purposes. ETPs mainly function to decrease toxicity of highly toxic waters so that they be clean enough not to harm the environment when disposed off.

HOW IS BIO MEDICAL WASTE (MANAGEMENT AND HANDLING) RULES, 1998 APPLICABLE?

Schedule M of Drugs and Cosmetics Rules, 1945 says that the Bio Medical waste has to be disposed off as per Bio- Medical Waste (Management and Handling) Rules, 1998. Schedule I,Category no. 5 of Bio-Medical Waste (Management and Handling) Rules, 1998 enlists‘Discarded Medicines and Cytotoxic Drugs i.e. waste comprising outdated, contaminated and discarded medicines.

WHAT ARE THE MAJOR NONCOMPLIANCES RELATED WITH BIO MEDICAL WASTE?

Two major non-compliances in the industry are related to:

  • Handling of Bio-Medical Waste: Bio Medical Waste has to be handled in safe manner without adverse effect to human health and environment and shall be segregated at thepoint of generation itself as per schedule II of the Rule.
  • Treatment of Bio Medical Waste in Sewage Treatment Plants (STPs) and/or Effluent Treatment Plants (ETPs): Bio Medical waste such as discarded medicines shall not be treated in STPs and ETPs, it shall be sent to a common Bio Medical Waste Treatment Facility or shall be incinerated before disposal as per schedule I of the Rule. A Sewage Treatment Plant is used to treat such type of wastes generated in households,kitchens or industries as sewage. The sludge so generated is used as ‘humus’ which is anorganic matter widely used as manure in farms therefore may lead contamination of ground water if it contains remains of Bio Medical waste in it. While in Effluent treatment plants, the sludge generated from treating trade effluents is disposed off as per Hazardous Waste (Management, Handling and Transboundary Movement) Rules, 1989.
HOW BIO MEDICAL WASTE CAN BE DISPOSED OFF?

Bio Medical Waste shall be disposed mainly by incineration, destruction and drugs disposal insecured landfills, there shall be no chemical pretreatment before incineration and deep burial shall only be available as an option in towns with population less than five lakhs and rural areas.The ‘Incineration Ash’ (Ash from incineration of any bio-medical waste) shall be disposed in municipal landfill only.

CONCLUSION

Keeping in mind that the Pharmaceutical Industry is one which shall have a persistent presence for years to come, considering this fact, we need to make it a practice that we adhere to a more sustainable approach and that shall only be possible by accepting the above mentioned practices. The only solution to the problems faced by the pharmaceutical industry is to categories the waste as Bio- Medical Waste, Sewage Waste or Trade Effluents and to use the disposal methods accordingly. This shall not only be a more pertinent approach but also legally viable.

About Author

Jayashree Swaminathan

Jayashree Swaminathan is currently working as the Chief Executive Officer at UnComplycate. With over 30 years of a proven track record advising corporates on their governance, risk and compliance mandates, Jayashree has been eyeing at a visionary approach to create a 100% compliant India Inc. With compliance as per passion, she possessed added skills in terms of business acumen in form of improving the financial performance, operating efficiency, cost control, revenue enhancing initiatives, practical system improvements, business development enhancement capabilities, etc.