#CDSCO Allows Relabeling of Old Medicines with Revised MRPs

Through a recent notice,  Directorate of General of Health Services, Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare has clarified that pharmaceutical companies can relabel old stocks of their medicines with the revised Maximum Retail Prices (MRP) applicable following implementation of the Goods and Service Tax (GST) regime.

The notice implied that on receipt of representation received from FICCI dated 7.7.2017 on the subject Stickering of Pharmaceuticals as per Act and Rules relating to Goods & Service Tax (GST),this office has no objection for alteration of label (stickering) by the manufacturers under rule 104A of the Drugs and Cosmetics Rules, 1945, if required for implementation of GST subject to provisions of Legal Metrology Act & Rules and other provisions of Act and Rules relating to Goods & Service Tax.

In a circular last week the Ministry of Consumer Affairs, Food and Public Distribution had already stated that manufacturers, packers and importers of pre-packaged commodities should declare the post GST MRPs of unsold stocks which were manufactured, imported or packed before July 1.

There had been lot of confusion among chemist regarding selling price of medicine till now and they had been selling old stocks of medicines at their pre-GST MRPs even after implementation of GST on 1st July. Incidentally  pharma companies were expected to declare the new MRPs on the batches they manufactured after July 1. Attached below are relevant notifications concerning the issue.

15 Medical Devices Notified as Drugs for Price Regulation: #CDSCO

Through a recent notice, Central Drugs Standard Control Organisation (CDSCO),Directorate General of Health Services, Office of Drugs Controller General India has informed about 15 notified medical devices classifying as drugs bringing them automatically under price regulation.

On a notice dated June 29, 2017, CDSCO stated that The Drugs & Cosmetics Act, 1940 is an Act to regulate import, manufacture,distribution and sale of drugs and cosmetics. It extends to the whole of India. Further, the Drugs & Cosmetics Rules, 1945 have been put in place which are updated from time to time for uniform implementation of the statutory requirements

The devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central govt by notification in official gazette, after consultation with the Board, fall under the definition of drug.

The list of devices, so far are appended includes:

1. Disposable Hypodermic Syringes
2. Disposable Hypodermic Needles
3. Disposable Perfusion Sets
4. In vitro Diagnostic Devices for HIV, HbsAg and HCV
5. Cardiac Stents
6. Drug Eluting Stents
7. Catheters
8. Intra Ocular Lenses
9. I.V. Cannulae
10. Bone Cements
11. Heart Valves
12. Scalp Vein Set
13. Orthopedic Implants
14. Internal Prosthetic Replacements
15. Ablation Device

The notice further informed that the health ministry has notified Medical Devices Rules, 2017, to bringing critical medical devices like stents, orthopaedic implants and diagnostic equipment under stringent regulation,which will come into force with effect from 1st day of January, 2018.

Criteria for Classification of medical devices including in vitro diagnostics have been specified in Rule 4, Chapter II of the rules which deals with regulation of Medical Devices in Indian context and in line with International Classification.

“It is expected that the importers, manufacturers, distributors and supply chain personnel shall voluntarily adhere with the safety, performance and quality aspects as stated in the said medical devices Rule, 2017 for creating proper eco-system for its effective regulation.In order to facilitate the process a special cell has also been created consisting of concerned JDC (I), DDC (I) and ADC (I) to address the issues, if any.” the notice added

A draft list of Medical Devices and in vitro diagnostics along with their risk based classification is annexed. Attached is the notification regarding the same.

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Check out #NPPA new Mobile app to verify Costs of Medicines

Public will now be able to track the information regarding their medicines they have been prescribed, their availability and prices through a new application on their smart phones. A new application known as ‘Pharma Sahi Daam’ has been introduced by NPPA that will help consumers to know the prices of scheduled medicines and non-scheduled medicines which are under price regulation after the implementation of the Goods and Services Tax (GST).

‘Pharma Sahi Daam’ is an online search tool which will indicate the MRP of the medicines (inclusive of VAT). This app will facilitate consumers to verify whether medicines are being sold within the approved price range and also to detect any case of overpricing by pharmaceutical company/chemist.

The app, developed by NPPA, provides information on the prices of scheduled medicines that are under price regulation as well as non-scheduled medicines. It also provides information about the nearest chemists and has a list of Jan-Aushadhi stores nearby

Apart from tracking the percentage of change in the cost of medicines, people can also register a complaint in case of overcharging of medicines on PHARMA JAN SAMADHAN website. (http://nppaindia.nic.in/redressal.html). 

Helpline number: 1800111255 
Whatsapp number; 9695736333 

To download the app click on the link given below. 

#NPPA fixes ceiling prices of 814 scheduled Formulations

New ceiling prices of 814 scheduled formulations became effective from today with drug pricing regulator NPPA fixing the cap in sync with the new GST regime. These formulations include medicines used for treatment of cancer, HIV, diabetes and infections among others. In a notification, National Pharmaceutical Pricing Authority (NPPA) said the fixation, revision of the prices of 814 scheduled formulations were done under Schedule-I under Drugs (Price Control) Amendment Order, 2016 under DPCO, 2013. 

Union Chemicals and Fertilisers Minister Ananth Kumar had said yesterday that NPPA will work out a mechanism ensuring patients do not pay more for drugs whose prices are expected to go up after the GST implementation. NPPA has already said that prices of around 78 per cent of ‘actively used’ drugs will remain unaffected after the rollout of the Goods and Services Tax (GST), which took effect today. “Price of drugs where partial increase is expected due to roll out of GST will not be passed on to consumers as NPPA is working out a mechanism in this regard,” Kumar had told reporters. He had further stated NPPA is working out a mechanism “to subsume for partial increase of retail prices of some drugs”. Kumar reiterated that “prices of life saving drugs and essential drugs rates will come down with reduction in GST rate”. The regulator had earlier indicated that the prices of majority of essential drugs would increase by up to 2.29 per cent when the GST regime kicks in. 

Before #GST, #NPPA Releases Ceiling Price of 761 Medicines

Drug price regulator NPPA on Tuesday announced provisional ceiling prices of 761 medicines, including anti-cancer, HIV, diabetes and antibiotic, with a majority being reduced ahead of the GST implementation. The National Pharmaceutical Pricing Authority (NPPA) said however that the actual increase or decrease in prices after the roll out of new indirect tax regime is expected to be in be in the range of 2-3 per cent depending on states. “In order to facilitate smooth implementation of GST 

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