Last Updated on October 14, 2024 by The Health Master
The National Pharmaceutical Pricing Authority (NPPA), the drug price watchdog of the country, has said that there can be no bar on it taking corrective measures if it finds out that some inconsistency or errors occurred while fixing the retail price of drugs, and the Drugs Price Control Order (DPCO) also does not bar it from doing the same.
It was taking a corrective measure related to the retail price notification for a vitamin product manufactured by Ravenbhel Healthcare and marketed by Mankind Prime Labs after it identified an error in the database based on which the price was fixed.
The NPPA, in its 103rd meeting of the Authority recently, revised the retail price notified for Vitamin D3 Oral Solution for 5 ml containing Cholecalciferol IP (in nanodroplet form) of 60,000 IU, which was fixed through an order on May 9, 2022.
The Authority noted that the price of the said product, manufactured by Ravenbhel and marketed by Mankind Prime, was fixed at Rs 13.94 per ml in the 97th Authority meeting held on May 6, 2022, and notified on May 9.
However, an error was discovered in the Pharmatrac database, which is used by the NPPA to determine drug prices, while determining the price of the same formulation for Micro Labs Ltd (marketing) and Ravenbhel Healthcare for an application received in June 2022.
It has been identified that with respect to one of the line items Kidrich D3 60,000 IU drops 5 ml of Dr. Reddy Laboratories, it was appearing in Pharmatrac database at Rs 198 per 5 ml pack against Rs 49.50 per 5 ml as per web sources.
The authority then sought clarification from Pharmatrac and Dr. Reddy’s Laboratories.
Pharmatrac in its response in September confirmed that the correct price of the said stock-keeping unit is Rs 49.50 per ml, while Dr. Reddy’s confirmed that the price of Rs 198 is for the pack size of 4×5 ml of Kidrich D3 60,000 drops 5 ml.
The authority observed that if the data for the said line item is rectified, the corrected price for Mankind Pharma’s product would be Rs 11.70 per ml, as against Rs 13.94 per ml notified earlier.
In this context, the Authority observed that it is mandated to fix the retail price of drugs, and in the execution of this function, the analysis of data is carried out and prices are fixed as per the methodology provided in the DPCO, 2013.
“While doing the analysis of the data, NPPA may come across data inconsistencies, miscalculations,/errors that might have occurred.”
“If any such issues are discovered, the same may be corrected by the NPPA.”
“There can be no bar on NPPA to take corrective measures and the DPCO also does not bare the same,” it added.
In view of this observation, the authority approved the revised price for the product at Rs 11.70 per ml and also noted that the same shall be informed to the Department of Pharmaceuticals.
The meeting also fixed the retail price for 40 out of the 43 applications it received for retail price fixation, including for:
- Zydus Lifesciences’ trastuzumab 375 mg injection,
- Apex Laboratories’ glimepiride,
- Voglibose and Metformin extended-release tablet,
- Cadila Pharmaceuticals’ Cholecalciferol (Vitamin D3) oral solution,
- Mankind Prime Labs’ ibuprofen and paracetamol tablets;
- Myo-inositol melatonin and folic acid tablet;
- Olmesartan medoxomil and amlodipine tablet, among others.
Latest on National Pharmaceutical Pricing Authority (NPPA)
Latest notifications – DPCO / NPPA
Latest Notifications: EC Act (Essential Commodities Act)
FAQs – On DPCO: Drugs (Prices Control) Order, 2013
RIICO to develop Medical Devices Park
USFDA gives nod for Amphotericin B Liposome Injection
USFDA issues Form 483 with 10 observations to Aurobindo Pharma
USFDA gives approval for Potassium-deficiency drug
Govt starts drive against misuse of Antibiotics
Bar code or QR code for 300 brands: Govt notifies these drugs under Schedule H2
USFDA gives EIR to Aurobindo Pharma for its AP facility
Maha FDA to take action against bodybuilders involved in misuse of prescription drugs
Altering the contents of formulation without changing brand names
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
