Union government may consider the possibility of revising pollution control inspections of production plants to a once in five-year format from the current the practice of frequent and surprise checks.
The proposal is part of the government’s efforts to ensure a favourable environment to attract investments in India and restore the confidence of global investors in the pharma-biotech manufacturing sector, said Dr. VK Subburaj, secretary, department of pharmaceuticals (DoP) who was in Bengaluru recently.
Ministry of environment & forests, which has listed industries under red, orange and green categories based on the heavy pollutant discharges includes fermentation and pharmaceuticals under its Central Action Plan.
The simplification of central and state pollution control board inspections to once in five years is expected to provide much ease of operation for the pharma and biotechnology sectors which come under the red category industries identified by the ministry of environment & forests, said Dr Subburaj.
There are several grievances and criticisms about the pharma and biotech manufacturing plants as they are known to increase pollution for residential areas coming up in the vicinity of industrial zones earmarked for only manufacturing operations.
Since 2009, the Central Pollution Control Board’s Comprehensive Environmental Pollution Index and Assessment of Industrial Clusters has called for escalated deployment of on-line monitoring systems enabling better environment compliances by way of self-regulation. Now pharma and biotech units view this as the way forward to remain constantly compliant to the norms.
The CPCB is now assessing the norms and is proposing a revision. A revised concept note to this effect is underway. The suggestions and views of state pollution control boards (SPCBs) and state governments would be taken, said Dr Subburaj.
“We hope the proposal will come through and it would be the best that could happen to the pharma and bio-pharma industries. Moreover it would indicate to the potential global investor that safe environment practices along with simplified pollution inspections norms are being put in place,” noted Kiran Mazumdar-Shaw, chairperson Vision Group on Karnataka Biotechnology and chairman and managing director Biocon Limited.
The need of the hour is total compliance by all pharma-biotech industries. Only then SPCB inspections once in 5 years are relevant, said Kaushik Desai, general secretary, Indian Pharmaceutical Association and pharma consultant.
According to Dr. Gurudatta GG, chief executive officer & director, Estima Pharma, for the heavy polluting industries, once in 5 years pollution inspection is not advisable. Considering Indian industry owner mentality, they will take advantage of it and industrial pollution would increase heavily. It is advisable to revise the pollution inspections from frequent and annual checks to a once in five-year format based on the risk assessment of ICH Q9 guidelines. It should not be done directly once in five years. For instance, MHRA audits of pharma units is based on the risk assessment. If any company comes under high risk, then audit is done once in 6 months. In case of some major observations, then it is annual and for the less major observations then it is once in two years. Similarly MHRA sometimes audits once in three years. Therefore CPCB and SPCB also should carry out risk based inspections before they move towards once in five years checks.
However, in the same, way, the government should be industry friendly also. It should only have one audit in a year for companies adopting necessary steps to reduce the pollution. The government must acknowledge this and give clearance. Currently, SPCBs are troubling industries despite being complaint. Therefore the industry expectation is for more transparency from the SPCBs, pointed out Dr Gurudatta.