NPPA panel fixes retail price of Diclofenac transdermal patch marketed by Hetero Healthcare

The retail price of each 37.5 sq. cm transdermal patch containing Diclofenac Diethylamine IP 100 mg for Azista Industries (manufacturer) and Hetero Healthcare (marketer) has been set at Rs. 31.25 per patch, excluding GST.

This recommendation came during the 38th meeting of the 'Multidisciplinary Committee of Experts' meeting, held on January 24, 2022, under the convenorship of Dr. Vinod Kotwal, Member Secretary, through video-conferencing.

Diclofenac is a phenylacetic acid derivative and a non-steroidal anti-inflammatory drug (NSAID). It acts by inhibiting cyclooxygenase (COX)-1 and-2, which are the enzymes responsible for producing prostaglandins (PGs). PGs contribute to inflammation and pain signalling. Diclofenac, like other NSAIDs, is often used as first line therapy for acute and chronic pain and inflammation from a variety of causes.

Transdermal patches are patches that adhere to the skin as a way to deliver drugs. They provide a specific, predetermined dose of medication which is absorbed through the skin and into the bloodstream. Transdermal diclofenac is used to treat short-term pain due to minor strains, sprains, and bruises in adults and children 6 years of age or older.

At a recent Multidisciplinary Committee of Experts meeting, the panel noted the retail price fixation of a 37.5 sq cm transdermal patch containing Diclofenac Diethylamine IP 100mg and observed that the data for the patch having Diclofenac IP 100mg (without mentioning the patch size) was available in the Pharmatrac database and the proposed retail price based on the data for the month of May 2021 came to Rs. 39.65 per patch, excluding GST.

The Committee further noted that Hetero Healthcare has sought a retail price of Rs. 31.25 per patch, excluding GST.

After detailed deliberation, the Committee opined that the drug strength (i.e., Diclofenac 100mg) in the patch is to be considered for fixation of the retail price.

The size of the patch is not relevant as the therapeutic efficacy depends on the dosage strength of the drug, the committee stated.

Accordingly, the Committee considered the retail price of Rs. 39.65 per patch excluding GST as the worked out price and recommended the retail price of each 37.5 sq. cm transdermal patch containing Diclofenac Diethylamine IP 100 mg for Azista Industries (manufacturer) and M/s Hetero Healthcare (marketer) at Rs. 31.25 per patch, excluding GST, being lower than the worked out price.