Wyeth claims $960 mn from Sun Pharma in Protonix case

Wyeth Pharmaceuticals Inc is seeking $960 million in damages from Sun Pharmaceutical Industries for alleged patent infringement in launching a generic version of acid reflux drug Protonix in the United States, the Indian company said.

The original patent relating to Protonix, known chemically as pantoprazole sodium, is held by Swiss drugmaker Nycomed and was licensed to Wyeth, which is now owned by Pfizer.

PIL filed against illegal drug trials

The Supreme Court of India today admitted a Public Interest Litigation (PIL) regarding the alleged illegal clinical trials that were conducted on adults, children and mentally ill patients across the country. The PIL was triggered by the recent news reports that found illegal and unethical drug trials were conducted on mentally challenged patients at the M G M Medical College in MP.

CCI cracks down on pharma companies for unfair trade practices

The competition commission of India has cracked a whip on the Indian drug manufacturers for encouraging unfair trade practises by colluding with wholesale drug lobbies. The CCI last week has asked drug manufacturers to furnish various documents and details pertaining to the problems of drug stocks, the product information services, their dealing with pharma distributors and reasons for selling drugs at MRP and not at lower prices, and alleged threats, instances of boycott.

Indian Pharma Firms Supports Price Regulation

In what could be a shot in the arm for government, the domestic pharma industry has endorsed price regulation model as suggested in the draft policy, subject to certain exemptions for indigenous research drugs.

National Pharmaceuticals Pricing Policy may cost pharma firms Rs 3,000 crore: Industry

The pharmaceutical companies may suffer sales loss of Rs 3,000 crore if the government's span of control increases, as proposed in the new pricing policy for the medicines, a section of the industry said.

RBI notifies new FDI norms for pharma sector

The Reserve Bank on Friday notified new rules doing away with automatic approval for foreign direct investment (FDI) in existing pharmaceutical companies. Tightening the norms, the government had last month done away with automatic approval of FDI in the existing pharmaceutical companies.

Scope, Implications of Section 3(d) Of the Indian Patents Act, 1970 (As Amended)

Under Indian patent law, there are certain inventions which are deemed specifically not patentable.

These are identified in Section 3, and the sub-clause of that section which is relevant with respect to the infamous Novartis case pending before the Chennai High Court and now also IPAB [Intellectual Property Appellate Board] is sub-clause (d) of Section 3.

DCGI to issue guidelines on compensation to clinical trial victims

With the increasing incidents of deaths and injuries related to clinical trials coming into the open periodically in the country, the Drugs Controller General of India (DCGI) will soon issue guidelines on providing proper compensation to the victims of the trials.

National List of essential Medicine 2011 (NLEM 2011)

National List of Essential Medicines of India 2011 (NLEM 2011) is a list of medicines, prepared by the Ministry of Health and Family Welfare, which are considered essential in India. The first such list was released in 1996. That list was subsequently revised in 2003. The latest list prepared and released in 2011 addresses the issues of changing disease prevalence in the country and the associated treatment modalities, besides taking into consideration the new medicines which are now available.

What is the "Drugs (Prices Control) Order (DPCO, 1995)”?

The Drugs Prices Control Order, 1995 is an order issued by the Government of India under Sec. 3 of Essential Commodities Act, 1955 to regulate the prices of drugs. The Order interalia provides the list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by Govt., penalties for contravention of provisions etc. For the purpose of implementing provisions of DPCO, powers of Govt. have been vested in NPPA.

What is NPPA and its role in Price Control of Pharma Products?

What is NPPA?

National Pharmaceutical Pricing Authority (NPPA) was established on 29th August 1997 as an independent body of experts as per the decision taken by the Cabinet committee in September 1994 while reviewing Drug Policy.

The Authority, interalia, has been entrusted with the task of fixation/revision of prices of pharmaceutical products (bulk drugs and formulations), enforcement of provisions of the Drugs (Prices Control) Order and monitoring of the prices of controlled and decontrolled drugs in the country.

 NPPA is an organization of the Government of India which was established, inter alia, to fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995. 

The organization is also entrusted with the task of recovering amounts overcharged by manufacturers for the controlled drugs from the consumers.

It also monitors the prices of decontrolled drugs in order to keep them at reasonable levels.

Worlds Major Regulatory Affairs Authorities

1. World Health Organisation (WHO)
2. US Food and Drug Administartion (USFDA) - USA
3. European Medicine Agency (EMEA) - Europe
4. Japanese Pharmaceuticals and Medical Devices Agency (PMDA)
5. Medicines and Healthcare products Regulatory Agency (MHRA)
6. Therapeutic Goods Administration (TGA) – Australia
7. Central Drug Standard Control Organization (CDSCO)- India
8. State Food and Drug Administration (SFDA) - China
9. Health Canada - Canada
10. National Health Surveillance Agency (Anvisa) – Brazil

PHARMEXCIL (Pharmaceuticals Export Promotion Council)

PHARMEXCIL is short form of "Pharmaceuticals Export Promotion Council"

It is set up and governed by Ministry of Commerce & Industry, Govt. of India

About the PHARMEXCIL:

The dynamic growth of Indian Pharma Industry, a knowledge based industry, and the recommendations of four major Pharma associations made the Ministry of Commerce & Industry to realize the need for separate export promotion council.

Accordingly, Pharmaceuticals Export Promotion Council (PHARMEXCIL) has been set up on 12.5.2004. 

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