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news.The Bulk Drug Manufacturers Association (BDMA) of India will request the Indian government to allow drug makers to switch product lines without applying for a new licence. At present, it is mandatory for drug manufacturers to apply for a fresh licence each time they want to change formulations.
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Drug compositions were dynamic and customers switched to new drugs with extra features in a very short period. But, officials demanded a fresh licence to change formulation which resulted in loss of time for firms. Consequently, the shelf life of few chemicals has also reduced, says M Narayana Reddy, President of BDMA.
Mr Reddy said: “Change in a formulation will not increase the pollution load of a company. Many bulk drug manufacturers are small scale industries and it is not viable for them to adopt new processes continuously.” BDMA will exercise the legal available option, as interpretation of pollution norms is subjective. The government should promote small units by establishing effluent treatment facilities, says Reddy.
T Rajendra Reddy of Andhra Pradesh Pollution Control Board, said: “Bulk drug manufacturing companies are recognised as red hazard companies by the Ministry of Environment and Forests. They are among the companies causing high pollution.
“Companies should upgrade processes to reduce the concentration of total solvent dissolved before sending it to the common effluent plant. We cannot allow them to pollute in the name of making drugs.” Companies need to invest 10 to 20% of the turnover to enhance their processes based on size and scale of operations, he added. – as quoted in business-standard.com