Indian Drug Manufacturers Association (IDMA) has sought clarity from the Ministry of Environment and Forests (MoEF) on its interpretation of hazardous waste and byproduct. MoEF published a notification on April 04, 2016 defining what would be waste and what was a byproduct.

In the past, as per the notification dated 24 September 2008 published by the MoEF there was no clear definition of what was considered waste and moreover there was no special mention of by-products and all material produced by a process that was not the intended product were being mistakenly classified as waste.

A submission in this regard has also been made to chairman of Gujarat Pollution Control Board (PCB), environment minister and other concerned officials.

A clarification has been sought with reference to the notification highlighting how the notification has differentiated between hazardous waste and by-product by clearly stating that if the production of a certain chemical was unintended during manufacture of the intended API or pharmaceutical intermediate, but it could be used as such, then it would not be regarded as hazardous waste.

Thus ammonia and acids produced by manufacturing processes should be classified as byproducts of the manufacturing process and not waste.

Moreover, this same classification of hazardous waste were also being applied to spent solvent. These items were not waste, they were purified to a certain purity, used for a given application and this has been going on for decades without any incidence of threat to the environment. This would not only save costs, but also promote re-use/recycling.

The notification stated that waste means materials that are not products or by-products for which generator has no further use for the purposes of production, transformation or consumption.

The explanation to the definition clarified further that for the purpose of this clause (I) waste includes the materials that may be generated during, the extraction of raw materials, the processing of raw materials into intermediates and final products, the consumption of final products and through other human activities and excludes residuals recycled or reused at the place of generation and (ii) byproduct means a material that is not intended to be produced but gets produced in the production process of intended product and is used as such.

Hazardous waste rules do not permit sale of spent solvents. API industry used solvents at various places of manufacturing and purification stages. Many times they had to use fresh solvents as per Good Manufacturing Practices (GMP) requirements. API industry was forced to dispose off spent solvents as hazardous waste to only selected units instead of getting return on sale. This indirectly leads to increase in cost.