Zydus challenges ceiling prices for 8 formulations, DoP rejects review
In yet another stern stance on implementing the new pharmaceutical pricing policy, the Department of Pharmaceuticals (DoP) has rejected the review petitions by Zydus Healthcare which challenged the price fixation done by the National Pharmaceutical Pricing Authority (NPPA) in case of its eight formulations.
DoP asks NPPA to reconsider retail price fixation on Abbott’s
The DoP took up the matter and examined the argument from both the sides, before arriving at a decision to remand the review petition to the NPPA. Abbott, in its review application said that the NPPA fixed the retail price for the formulation based on recommendations of the Multi Disciplinary Committee (MDC) of Experts, using the average of
DoP asks companies to revise MRP of drugs on which GST rates have been
The Department of Pharmaceuticals (DoP) has directed all the manufacturers and marketing companies to revise the maximum retail price (MRP) of drugs or formulations on which Goods and Services Tax (GST) has been reduced taking into effect the revised rates of GST.
DoP clarifies on NPPA’s price-capping powers, under PMO supervision
According to DoP, it was brought to its notice that the NPPA has sought additional information — such as detailed agreement or contract between the manufacturer and marketer — from the applicant seeking price approval for new drugs under form-1 of DPCO, 2013.
DoP asks NPPA to review, verify Bharat Serum and Vaccine's request
The Department of Pharmaceuticals (DoP) has issued an order disposing the review application of Bharat Serum and Vaccine (BSVL) to the National Pharmaceutical Pricing Authority (NPPA) instructing to verify the applicability of GST factor by cross-checking the documents submitted by BSVL pertaining to the formulation Human Normal Immunoglobulin.
- What does NPPA say about public procurement?
- NPPA has reinforced that the main objective of the public procurement is to award the most advantageous result – from a broader perspective – rather than merely securing the lowest price or selecting the most advantageous bid from either a technical or price and technique combination perspective.
- How to promote a product in a distribution agreement in Brazil?
- The parties to the distribution agreement are free to stipulate in the agreement how to promote and advertise the contract products. However, the advertising and promotion of certain products are subject to regulations in Brazil, and those regulations must be followed.
- Why is Brazil implementing and improving regulatory policy?
- By implementing and improving regulatory policy, Brazil has been reducing regulatory burdens for U.S. exporters and increasing mutual understanding of U.S. and Brazilian regulatory systems to enable better promotion of bilateral commerce and investment.
- What are the different types of distribution agreements in Brazil?
- However, distribution agreements are considered non-typical agreements, and therefore, the parties are free to introduce any provisions that better suit their needs, if those provisions do not violate applicable law. For this reason, four types of distribution agreement are recognized in Brazil: Exclusive distribution.
- When does NPPA come into effect?
- However, recently enacted Law # 14,133/21 (the New Public Procurement Act or “NPPA”) has altered the framework for Government procurement proceedings and contracts entered with public entities. Although it came into force on April 1st, 2021, the rules will only be effective as of April 1st, 2023, then revoking Law # 8,666.
- What are Brazil's regulatory agencies Law & Economic Freedom Law?
- In 2019, Brazil passed the Regulatory Agencies Law and the Economic Freedom Law, which make certain GRPs, like public consultation requirements and the use of a regulatory impact analysis (RIA), legal requirements for all Brazilian regulating agencies.
