Drug Information Bulletin (Electronic)

Volume: 4

Drug Information Centre (DIC) Indian Pharmaceutical Association, Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Number: 19

Content DCGI office clarifies that there is no provision for issue of GMP certificates under D&C Rules Regulate price of life saving drugs: B.N. Sharma, Principal Secretary, Dept. of Health, Govt. of India World Mosquito Day celebrated on 20th August PMO renews patent debate Interesting Books on Palliative care Readers Column:

DCGI office clarifies that there is no provision for issue of GMP certificates under D&C Rules Even as almost all the drug procurement agencies have made it mandatory for the drug manufacturers to produce GMP certificate for participating in the tenders, the office of the drug controller general of India (DCGI) has clarified that there is no provision for the issue of (Schedule M) GMP certificates under the Drugs and Cosmetics Rules. Replying to a Right to Information (RTI) application filed by a Noida-based pharma manufacturer, the Central Public Information Officer of the Central Drugs Standard and Control Organization (CDSCO) said that there is no provision for the issue of (Schedule M) GMP certificates under the Drugs and Cosmetics Rules and there is no specified form for issue of GMP certificate under the Drugs and Cosmetics Rules.
Dr. Tulsi Chakrabarti-Hony. Secretary, IPA-Bengal Branch handing over a memento to Dr. Partha Nandy, Director, US-Head, Advanced PK/PD Modeling and Simulation, Clinical Pharmacology, Janssen, Pharmaceutical Companies of Johnson & Johnson at IPA auditorium on 31.07.2010 at Kolkata in appreciation of his lecture on Pharmacometrics: The Quantitative Aspect of Pharmacology

Annoyed over the drug procurement agencies' 'illegal' demand of submitting GMP certificates for participating in the drug tenders, the pharma manufacturer asked through the RTI: Whether there is any provision for issue of Schedule M (GMP) Certificate by State Licensing Authorities under Drugs and Cosmetics Act 1940 and Rules made there under. If so, kindly intimate Rule number? Other questions include: Whether there is a specified form for issue of GMP Certificate under the Drugs and Cosmetics Act 1940 and Rules made thereunder?, and Whether a Drug Manufacturing Unit which has a valid License is considered GMP Compliant Unit or Not?. For the query Whether a Drug Manufacturing Unit which has a valid License is considered GMP Compliant Unit or Not?, the reply from the DCGI office was 'yes'. The drug manufacturers in the country, especially the small and medium sectors, are upset over the way the drug procurement agencies, including RITES, Railways, state government agencies, etc, are making it mandatory to produce GMP certificates for taking part in tenders. The drug manufacturers say that such conditions have no legal validity as the DCGI office has clarified that a drug manufacturing unit which has a valid license will be considered a GMP compliant unit. Insistence on such conditions will virtually disqualify the small and medium pharma companies from participating in the tenders for supplying medicines to these departments, they regret.
Source: pharmabiz.com

2 by pharmaceutical majors, the state medical and health department has asked the Centre to regulate prices of medicines, which are used to treat serious aliments like cancer and Aids. Principal secretary, health, BN Sharma has shot-off a letter to the pharmaceutical department of government of India underlining the discrepancy in rates of medicines manufactured out of same salt by different companies. This is for the first time, in recent years that an issue concerning inflated prices of medicines has been taken up by the state officially. It also points out the vast differences in prices of same drugs in market and seeks government intervention to end monopolistic abuse by drug manufacturers. Sharma argued that medicines prescribed for serious ailments should be included under life saving drugs and their rates should be controlled by the government. He proposed that the prices of 354 drugs listed by the World Health Organization as life saving medicines should be regulated. At present prices of only 74 medicines are regulated in the country. "The national pharmaceutical pricing authority has de-regulated 273 out of 347 drugs whose prices were originally regulated in 1979 on the premise that in the open market competition, the drug prices will even out; this policy is not admissible," Sharma said. He offered a case in point: An injection (Irinotecan salt-based) used to treat colon or rectal cancer is being sold in the market by a major pharma company for around Rs15,000 when the injection, made out of the same salt, is available under different brands for just Rs1,500. Officials with the state drug control department said that there are numerous cases like these where the patients are

Regulate price of life saving drugs: B.N. Sharma, Principal Secretary, Dept. of Health, Govt. of India To bring an end to the unfair trade practices

3 unaware of cheaper alternatives with same salts. "A drug company is retailing a set of 5 capsules containing Temozolomide to treat astrocytoma for more than Rs34,000; the same drug is available under other reputed brands for Rs9,000-9,500," the official said. DrugsControl.org in a study has found that Irinotecan is manufactured by Dr Reddy, Merck (India) and Miracalus Pharma Pvt Ltd in the Brand Name of Irnocam Inj, Irinomil Inj and Torsirin Inj respectively. Irnocam Inj 40 mg is priced at Rs. 1969/-;100mg Inj at 4195/-, Irinosil 40 mg Inj at Rs. 2060/- and 100mg/ 5 ml at Rs. 4390/-, Torsirin 40 mg Inj Priced at 1700/- and 100 mg at Rs. 3200/Temozolamide is manufactured by Dr Reddys and Celon Labs in the brand name Glioz and Temolon Caps in different strengths. Glioz 20 mg/ 5 Caps is priced at Rs. 2255/-; 100 mg/ 5 Caps at 9928/-; 250 mg/ 5 Caps at Rs. 24035/-, Temolon 5 mg/ 5 Caps Rs. 480/-; 20 mg/ 5 Caps Rs. 1900/-; 100mg / 5 Caps Rs. 9200/- and 250 mg/ 5 Caps Rs. 21100/Officials in the government said that the companies, which sold higher priced medicines offered a better share of profits for the chemists and retailers. A senior health official said that, "Even if a chemist offered a cheaper alternative with same salt, he would do so at the risk of losing his license because the rules bind him to follow doctor's prescription." In order to make affordable life available to the people, department has proposed companies retail their products of the original salt.
Source: DrugsControl.org

Sir Ronald Ross World Mosquito Day celebrated on 20th August On August 20, 1897, Sir Ronald Ross of the Liverpool School of Tropical Medicine discovered the role of the Anopheles mosquito in the transmission of malaria. To mark the finding, Dr. Ross declared August 20 to be World Mosquito Day. More than 100 years later, NIAID continues the fight against mosquito-borne illness through research on mosquitoes and the diseases they transmit. From malaria to dengue, West Nile virus to filariasis, NIAID supports domestic and international investigators who aim to one day diminish or prevent the transmission of pathogens to humans through the bite of infected mosquitoes. For more on NIAIDs Vector Biology Research Program, visit: http://www.niaid.nih.gov/topics/vector/Pages /Default.aspx. Also visit NIAIDs health and research topic pages on various diseases transmitted by mosquitoes, such as:

saving drugs the health that drug in the name

Dengue Fever: http://www.niaid.nih.gov/topics/dengu efever/pages/default.aspx Malaria: http://www.niaid.nih.gov/topics/Malari a/Pages/default.aspx West Nile Virus: http://www.niaid.nih.gov/topics/westni le/Pages/default.aspx

Indian Patent Act that disallows patenting of incremental innovations without significant advantages. Data exclusivity, patent linkage and allowing patents to incremental innovations by amending the section 3 (d) of the Patent Act have been the most important demands of the global pharmaceutical companies. The United States Trade Representative, in its annual Special 301 Report, also highlights the need for a strengthened intellectual property regime as one of the requirements before India can be removed from its watch list. This report relates to the agencys views on the adequacy and effectiveness of US trading partners protection of intellectual property rights. In a note to the departments of health, industrial policy and promotion, legal affairs and pharmaceuticals, PMO wanted the issues raised by OPPI on the need for regulatory data protection and amendment to the Patent Act be examined by each department and submit their views. The Department of Pharmaceuticals has been asked to coordinate the matter.
Source: http://www.business-standard.com/india/news/pmo-renewspatent-debate/405051/

Source: National Institute of Allergy and Infectious Diseases (NIAID) [niaid@service.govdelivery.com]

PMO renews patent debate The Prime Ministers Office (PMO) has sought the opinion of various stakeholder departments on the need for further amendments to the patent law to introduce some of the controversial provisions that were kept out during the previous amendment to the Indian Patent Act five years ago. The move, which comes ahead of the India visit of US President Barack Obama, is significant as many of these issues have been raised by multinational pharmaceutical companies. The PMO suggestion is based on a submission made by the Organisation of Pharmaceutical Producers of India (OPPI), the association representing the global pharmaceutical industry in the country. OPPI has sought a more stringent intellectual property regime than what is compulsory under the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement of the World Trade Organization. The proposed changes, if enacted, can have a significant impact on the way patents are granted in the country. The industry lobby group has sought a review of the scope of a specific section of the

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