SME Pharma Industries Confederation (SPIC) has urged the Union chemicals ministry to make inspection of facilities mandatory before issuing permissions to import APIs from China, which accounts for around 70 per cent of API requirement in the country, to ensure quality of products.
In a representation to the chemical ministry, the confederation suggested that officials from DCGI office and technical officers from chemicals department should carry out inspections. "Mere submission of documents should not qualify for grant of registration for import of APIs. This procedure of inspection is even being carried out by developing countries like Ghana, Nigeria, etc", the SPIC letter said.
Outlining suggestions to keep prices of drugs in the country under check, the SPIC said that the import of drug intermediates should be made duty free and regular duty be imposed on import of APIs. Such steps will strengthen our bulk drug industry, especially in the small-scale. It also suggested that government schemes like PTUF and CCLS and involvement of NIPER should also be strengthened to make the industry self-sufficient to meet the turbulences in prices of APIs.
SPIC pointed out that after supplying the APIs at low prices to India and having made bulk drug industry, especially the small scale sector financially unviable, China has increased prices of APIs, impacting the prices of drugs in India. "For example, the price of penicillin came down to USD 5 per BOU, which made our fermentation industry to close down. Having done so, the Chinese manufacturers have raised the prices of penicillin to USD 20 per BOU. When the Indian manufacturers started taking steps to revive their closed units, the price of penicillin was brought down to around USD 15 per BOU. Same is the case of erythromycin thiocyanate from China where the prices were USD 38 per KGA and was raised to USD 75 per KGA. You are well aware that antibiotics made from penicillin etc. have a market share of 60 per cent in India,'' SPIC said.
The federation suggested that NIPER and other research institutions in the country should give liberal support to small scale pharma industry for manufacture of APIs and drug intermediates by promoting green chemistry. Chinese drug industry is also being fully supported by Chinese scientific institutions in improving their technologies, it said.
"Government should identify the ten highest selling drug molecules in the world and make policies to achieve excellence in manufacture of the same, at every stages with emphasis on costing from fine chemicals to drug intermediates and ultimately to APIs/medicines,'' the representation said.