Facing disruption in supply of active pharmaceutical ingredients (APIs), pharmaceutical manufacturers from the region have requested the Centre to set up an “API Monitoring Cell” to check the prices and quality of imported and domestic manufactured ingredients. According to the industry, this will prevent black marketing and overcharging of the APIs, at the same time ensuring genuine products to the manufacturers. APIs are the key ingredients that give a drug its medicinal effects and India is largely dependent on China. With the disruption in supply of APIs from China, which accounts for 80% of APIs’ import to India, the prices of API have seen huge fluctuations in the past two years from 10% to 300%. “Recently, we have sent our representation to the Centre to set up a monitoring cell. Currently, there is no such framework to check the prices of the raw material on the lines of National Pharmaceutical Pricing Authority (NPPA) that controls the prices of pharmaceutical drugs in India. The cell will not only ensure genuineness of the raw material but also keep a check on the prices,” said Himachal Drug Manufacturers Association (HDMA) president Rajesh Gupta. HDMA represents 650 out of 750 pharma companies in the state. The total turnover of the industry in Baddi-Barotiwala-Nalagarh belt is around Rs 40,000 crore and has a significant share in the Rs 1.10 lakh-crore domestic market.
The manufacturers added that government should make mandatory usage of bar codes on every container carrying raw material. This will help the government track and authenticate them at each stage of their journey from API manufacturing facility to formulation unit. “The setting up of API monitory cell will ensure that genuine APIs reach formulation units. We have asked the ministry that every container carrying APIs should be bar coded so that its shipment can be tracked. Many a times it happens that once the container of APIs is disposed by the formulation unit, it is again filled by unscrupulous elements and sold to the manufacturers,” said HDMA chief adviser Satish Singhal. The manufacturers also stressed that stringent and regular inspections are required to monitor import as well as manufacturing of APIs in India through various testing specifications in order to avoid NSQ (Not Standard Quality) in India. Industry executives said the anomalies in the current regulatory framework were destroying the indigenous manufacturing sector.
Bar coding the containers will also help in improving response time during shortage of drugs due to reduction in the API supply, said a manufacturer. It could also help create better policies to promote the domestic industry. A senior official in Pharmaceuticals Export Promotion Council of India suggested as far pricing is concerned, the government can keep a tab on the price by monitoring the price of the APIs at which it is imported and sold to the manufacturers. Many a times, bulk importers book a huge profit due to raw material shortage.
Total domestic market: Rs 1.30 lakh crore (approx)
Industry’s demand: Setting up of APIs’ monitoring cell
Purpose: To regulate prices and quality of APIs
Benefits: Price stability, boost to indigenous manufacturing
Source : https://www.tribuneindia.com
Published on: January 30, 2019