Drugmakers in India face the prospect of more inspections under new guidance from the country’s price setting agency, the NPPA.
The plan – set out in a document posted on the organisations website – is for National Pharmaceutical Pricing Authority (NPPA) inspectors to assess manufacturing facilities when they visit them as part of the process of fixing the prices of essential medicines.
The idea is that plant visits will be conducted to verify data submitted by the company in question and – if it is deemed necessary – to collect additional information on manufacturing processes.
"Plant visits are to be made for verification of data and collection of additional data, understanding product, process, etc. and holding discussions with the officials of the company."
The NPPA will look at parameters such as yields, capacity assessment and utilization, maintenance of plant and machinery, cost of raw material, research and development and expansion of manufacturing plants and replacement of machinery.
At present the NPPA set the price of 74 bulk pharmaceutical products, although this is due to increase to 348 under plans issued by Government Ministers in September .
The organisation did not say what prompted the decision to conduct inspections, but a report in India’s Business Standard suggests it is part of an effort to get drugmakers to justify the prices they charge for the products based on production costs.
An unnamed spokesperson told the paper that: “There are often clashes between data sent by companies and what we gather through other sources. The interpretation of data could also vary. We often arbitrarily accept whatever is lower. So, the effort is to maintain uniformity in approach and avoid subjectivity in interpretation.”