PHARMA LITERATI

Reportedly, prices of APIs/KSMs for hydroxychloroquine, azithromycin and paracetamol have increased exponentially in the last three months The National Pharmaceuticals Pricing Authority (NPPA) has asked the Central Drugs Standard Control Organisation (CDSCO) to assess procurement and price issues regarding APIs for hydroxychloroquine, azithromycin and paracetamol. Following that, the CDSCO has issued a letter to all the States and Union Territories drug controller to understand the issues regarding the same for APIs and key starting materials (KSM) in the country. This step is being taken by the authorities after media reports and representation by different pharma associations about the surge in the prices of APIs in the country. Dr Hemant Koshia, Commissioner, FDCA said, “We have also come to know about the increase in the prices of these APIs in the market. And it happened because some traders and small manufacturers have spiked their prices by almost 10 per cent. And, con...

Low-cost Chinese active pharmaceutical ingredients (APIs) continue to throng the Indian market through illegal route, posing a health risk to the people. APIs such as erythromycin stearate, used to treat a wide variety of bacterial infections, are being imported by certain Indian drug companies /traders from China without requisite registration certificates and the material is being sold at a very low price in India. A representation in this regard has already been made to Drugs Controller General of India (DCGI) and the matter is being investigated by regulatory authority. Last month, it was brought to the notice of the DCGI that erythromycin stearate of Shanong Sinder Technology, China was being openly sold by Chennai-based drug companies/traders. It is understood that the importers had lacked certificate of product registration of erythromycin stearate in India thus casting suspicion on quality and efficacy of the product. The API was being supplied by the importers i...