The National Pharmaceutical Pricing Authority (NPPA) is likely to take into account the additional cost incurred by companies towards overfills and overages during the production of price controlled formulations. The additional cost in these cases come from the cost of additional product/input needed to ensure the declared quantity or quality of the drug.

According to sources, NPPA has asked pharmaceutical associations like Organisation of Pharmaceutical Producers of India (OPPI) and Indian Drugs Manufacturers Association (IDMA) to furnish adequate data to establish the extent of additional expense that are being incurred by the companies in the process of making the drug of complete standards as per the Drugs and Cosmetics Act and Rules.

The overfills are becoming necessary to make sure that the exact quantity of the product as written on the tube/cover is available to the consumer. The overages are necessitated due to the shelf life stipulations as prescribed under the law. "We need to add more quantity of ingredients in the formulations if the potency of the product has to remain at the required level throughout the shelf life of the drug. The NPPA has not been considering these additional inputs of bulk drugs while calculating the cost of the final product," sources explained.

Recently, the associations succeeded in presenting their case before the authority in a convincing manner, it is learnt. They had organized a meeting for the NPPA experts where the officials were given a first hand account of what exactly goes into the making of a drug. The authority had several hours of discussion and has finally asked the associations to submit the data.

Sources indicated that NPPA is likely to compensate for the loss and come out with slight changes in their price calculation process in near future. NPPA officials also acknowledged the industry demand and informed that the authority is giving a serious thought in this regard.

Meanwhile, the exercise of finalizing revised conversion cost (CC) and packing charges (PC) norms is continuing with the Cost Accounting Branch (CAB) of the Finance Ministry. NPPA would be able to consider the changes only after CAB completes its assigned work.