The Indian Drug Manufacturers’ Association (IDMA) has sought clarification from the Department of Pharmaceuticals (DoP) to avoid any confusion in interpreting and implementing the Drug Price Control Order (DPCO) amendment 2016. The association is concerned over the clubbing of the formulations developed through incremental innovations such as sustained release or controlled release dosages with ordinary dosage forms in the draft working sheet by the National Pharmaceuticals Pricing Authority (NPPA).

The association is of view that different formulations should be considered separately and should not be clubbed with the ordinary dosage forms by NPPA.

The association in its representation to the DoP explained that the said clubbing is contrary to the directions of DoP and recommendations in the report of the core committees for the revision of National List of Essential Medicines (NLEM) 2015.

As per Schedule 1 under DPCO 2013, ‘Innovation in medicine must be encouraged. The formulations developed through incremental innovation or novel drug delivery systems like lipid/liposomal formulations, sustained release/ controlled release etc. should be considered as included only if specified in the list against any medicine. Such different formulations should be considered differently for purposes such as procurement policy, pricing etc.’

Explaining further the association said that Schedule 1 of DPCO 2013 clarifies that ‘if a tablet is included, other dosage forms like conventional tablets and capsules are considered as included’ and it is generally understood that conventional capsules are generally understood as hard gelatin capsules only and do not include soft gelatin capsules, which are manufactured with totally different technology, require different skills, machinery and equipment and entail different costs. By the stipulation soft gelatin capsules has been excluded from the definition of conventional solid dosage forms and hence from the NLEM 2015 (unless specified).

With the directions of DoP to NPPA to display draft working of the ceiling prices of formulations including Price to Retailer (PTR) and Moving Annual Turnover (MAT) on their website for 10 working days and to take into an account comments and additional data provided by the affected firms for finalising the Ceiling Prices (CPs) and Retail Prices (RPs). NPPA, in compliance has been displaying the draft working sheets on its website and the formulations developed through incremental innovations such as sustained release, controlled release dosages are being clubbed with ordinary dosage forms in the draft working sheets, informed IDMA.