Indian pharma companies have a lot of manufacturing sites across the country. However, the economics of scale of units here is different from China which results in high cost of their produce making formulators to depend more on Chinese produce.
Intermediates for the production of final API are sourced from China by major Indian manufacturers. In order to reduce the dependence of these intermediates, Indian companies need to explore on putting up facilities in dedicated pockets across India. The Department of Pharmaceuticals (DoP) shall identify probable states/locations for creating this infrastructure, along with state governments and private developers as collaborators.
India’s young manpower, vast areas of land in different states which are earmarked for pharma clusters shall be utilised for bringing in future facilities. Indian producers shall primary focus on quality and regulatory compliance and better capacities for economics of scale helping for a competitive pricing of their produce. Quality and regulatory compliance is a major issue for Indian pharma sector for both API and formulations for exporting units. Non-compliance to systems and procedures, data integrity and facility maintenance are the major concerns which are being highlighted by international regulatory authorities.
India’s thrust on R&D capabilities varies for developing methods of manufacture of intermediates as well as final bulk drug (API). It needs to be strengthened for shorter processes, better yields and safe reactions. During last two decades, India has shown a declining trend in producing good chemistry scientists as majority of people adopted engineering courses due to boom in IT sector.
A major concern for above is with respect to handling of hazardous waste as well as effluents and environmental discharges generated from these units. It is mandatory that the basic infrastructure for the treatment, storage/disposal of the above should be in place, before giving any permissions to start manufacturing activities. Additionally, manufacturers need to have adequate mechanisms that are maintained and complied as per CPCB norms and ISO 45001 and ISO 14001 standards.
We have educated manpower available across India, but lack skills to meet the industry requirements. We need to make changes in the curriculum for schools/colleges as applicable so that the students undergo skill development, along with regular curriculum. Even special training institutes shall be promoted by government or private players for the above requirement.
In Vizag, a district which was identified and promoted by the Government of Andhra Pradesh (undivided) is a strong foothold for API manufacturing in India. The Andhra Pradesh government had put additional emphasis by introduction of single-window system for approvals, which is a boon for this sector. Private players and government-operated SEZ and non-SEZ zones have come up and started operating, with some of these exclusively for pharma sector. Moreover, power availability is not at all an issue, as there is a common effluent treatment plant and hazardous waste disposal area for handling waste generated by the pharma sector.