As increased dependence on import of active pharmaceutical ingredients (APIs) from China is raising national security concerns, serious anomalies in the current regulatory framework are destroying the indigenous manufacturing sector, it is learnt.
The existing rules don’t allow a domestic manufacturer to go for capacity expansion or diversification to meet market demand without prior consent from pollution control boards (PCBs) even if there is no change in pollution load. The approval can take up to six months to arrive.
“The firms should be allowed to make changes in product mix and increase capacity if there is no change in pollution load after intimating the PCB concerned instead of waiting for their green signal. Moreover, as per existing norms, individual units which are connected to central effluent treatment plants (CETPs) are required to treat their effluent to the same level as mandatorily required by the CETP. This is double effort and leads to steep rise in capital expenditure,” Yogin Majmudar, chairman of bulk drugs committee, Indian Drug Manufacturers Association (IDMA), told Pharmabiz.
“The volume of effluent generated from API manufacturing is insignificant compared to large chemical plants. Wherever there is a functional CETP, connected units should be allowed to send effluent after neutralising it. With this single measure, treatment cost, which is more than 10 per cent of the total cost, will come down substantially. It will help us compete with Chinese firms in pricing,” Majmudar added.
Another major impediment to the indigenous industry is the extremely low registration and inspection fees for pharma product exporters to India. Inspection of API units is also not mandatory. China charges hefty registration fees and takes more than 2 years to grant permission.
If proper and regular inspections are conducted, many Chinese bulk drug exporters will be out of the game, industry sources say. The argument holds water as recently India’s drug regulator Drug Controller General of India (DCGI) has banned the import of ingredients of drugs from six major Chinese pharmaceutical firms citing quality issues and rule violations.
In its order, the Central Drug Standards Control Organisation (CDSCO) said the APIs supplied by these firms may lead to health risks. Similar orders have been sent out to port offices so that their products don’t enter the country.
According to official figures, India imports about 84 per cent of its API requirement. APIs worth Rs.13,853 crore were purchased from China in 2015-16 or 65.3 per cent of the Rs.21,217 crore total APIs consumed in the country. These included ingredients for essential antibiotics. The rest came from Europe, Japan and the US.
“As of now, there is no specified time limit for approvals for manufacture or export of new bulk drugs. Precious time can be saved by making approval procedures time-bound for all manufacturing permissions. For exports, NOCs may be dispensed with for all types of APIs as long as they confirm to Pharmacopeia standards certified by the manufacturer exporter,” an industry representative pointed out.
Instead of reforming archaic rules, the government is focused on announcing mega ventures, the person added. The much-publicised project to develop bulk drug manufacturing zones, which was expected to give the sector a fresh fillip, has hit the wall in the absence a conducive regulatory environment. API and intermediate units are spread across the country with a significant presence in four or five states. So the benefit of common facilities such as CETP, subsidised power and land availability is not available making the industry uncompetitive.