The Central government has constituted a high-level task force to formulate a roadmap for reviving the active pharmaceutical ingredient (API) sector amid growing concerns over an overwhelming dependence on drug imports from China.
The strategic group is headed by the minister of state for chemicals and fertlisers. The members of the team include secretary of Department of Pharmaceuticals (DoP), health ministry secretary or his representative, Director General of Council of Scientific and Industrial Research and the Drug Controller General of India. The panel would co-opt a member each from industry associations such as Indian Drug Manufacturers Association (IDMA), Indian Pharmaceutical Association (IPA), Bulk Drug Manufacturers Association (BDMA) and Organisation of Pharmaceutical Producers of India (OPPI). The industry body member should be at the level of a CEO.
The task force will study global API manufacturing practices, interact with relevant stakeholders and create a roadmap with implementable recommendations. It will also look into required interventions concerning Central and State governments and various regulatory bodies.
The setting up of a task force to develop the domestic API industry comes as no surprise as overdependance on Chinese products has been raising national security concerns against the backdrop of deteriorating Sino-Indian border relations. The neighbouring nation has already captured a 40 per cent share in the global market for APIs. According to official figures, India imports about 80 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.
The latest data by the Pharmaceuticals Export Promotion Council (Pharmexcil), an arm of the ministry of commerce and industry, also paints a bleak picture. The figures show that there is a spike of 50 per cent in the import of drug formulations and biologics from China in the last five years.
While welcoming the constitution of a top-level task force, the domestic drug industry representatives call for a conducive regulatory environment to fuel growth in the API sector. While China regularly tweaks its regulations to give a fillip to its industry, India is way behind in this area. Registration and inspection fee for pharma product exporters to India still remains extremely low. Inspection of API units is also not mandatory. On the other hand, China charges hefty registration fee 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 last year the DCGI banned the import of ingredients of drugs from six major Chinese pharmaceutical firms citing quality issues and rule violations.
Last year, the government announced mega bulk drug parks in various states and contemplated restrictions on imports to boost the domestic API industry. The special park project fizzled out in the absence of a supportive regulatory framework, said an industry source. “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 even if there is no change in pollution load. The approval can take up to six months to arrive,” he added.