At Chronicle Pharmabiz, a composite Editorial Team spread out at key centres nationwide brings you extensive reportage of the pharmaceutical industry each week.

At Chronicle Pharmabiz, a composite Editorial Team spread out at key centres nationwide brings you extensive reportage of the pharmaceutical industry each week. As we celebrate the 9th Anniversary of our publication, we look at some of the exclusive stories we did this year Satwant Reddy panel on data exclusivity for drugs gathering dust in health ministry Ramesh Shankar, Mumbai The Union health ministry appears to have put a decision on the long awaited data exclusivity policy on the backburner as more than one and a half years down the line after the Satwant Reddy panel submitted its report to the government, the ministry is yet to take a decision on the issue. More interestingly, there has been no serious discussion on the issue for the last several months. Jan 1, 2009 Vol 9, No 3 Health ministry to seek help from Comm ministry to deal with issue of counterfeit drugs Joseph Alexander, New Delhi The Union health ministry may seek the help of the Commerce Ministry to deal with the issue of redefining counterfeit drugs in a bid to safeguard the interests of the Indian pharmaceutical exporters. The issue is turning into a major controversy that may ultimately affect trade relations with other countries. The commerce ministry will be involved to mount concerted efforts against the alleged attempt by some developed countries and big multinationals to brand Indian generic drugs as counterfeit by redrafting the definition as proposed by IMPACT. Jan 1, 2009 Vol 9, No 3 Comm ministry asks cos to submit details of export cargo held up at EU ports Ramesh Shankar, Mumbai In its efforts to take up the issue of seizure of Indian drug shipments at European Union (EU) ports with the European Commission (EC) for a possible solution, the Union commerce ministry has started gathering specific information on the issue. The ministry has asked the industry to furnish details about seizures like the name of the port, date, product name, etc. Loaded with the detailed information on the issue, the commerce ministry will soon approach the EC for finding an amicable solution to the issue which was triggered when the EU countries started implementation of local patent rules rigidly. These EU rules stipulate that any product patent that has been granted in EU countries, if being transported through their countries, is also liable for confiscation under their patent law. Jan 8, 2009 Vol 9, No 4 Govt may ask pharma cos to curb unethical promotion of drugs by inducing docs Joseph Alexander, New Delhi A set of common guidelines binding on all pharma companies or a joint mechanism of the sort by the industry may be evolved soon to curb the unethical trade practices of inducing doctors for favours by some companies, thanks to a belated but strong resolve by the government to reign in on the practice. Jan 22, 2009 Vol 9, No 6 Industry to move court on Spurious Drugs Bill soon to curb inspectors' powers Ramesh Shankar, Mumbai Apparently apprehensive of the Union health ministry's actions in addressing the concerns of the industry over the recently passed Spurious Drugs Bill, the beleaguered industry is preparing to move court to save the genuine drug manufacturers from the harassment of the drug inspectors who have been given sweeping powers in the Bill which received President's assent recently. Feb 5, 2009 Vol 9, No 8 Thousands of M Pharm students face disqualification by PCI due to illegal admission Ramesh Shankar, Mumbai Thousands of M Pharm students, studying in various deemed university colleges including NIPER, Hyderabab, may face disqualification by the Pharmacy Council of India (PCI) as these colleges have given admission to 200 to 600 students against the approval of only 18 students per batch. Feb 19, 2009 Vol 9, No 10 DRL identified potential herbs to develop malaria drug Joseph Alexander, New Delhi The Defence Research and Development Organisation (DRDO) has succeeded in identifying two species of herbs carrying elements for a potential drug for malaria and is hopeful of bringing it to the market within two years as an alternative to existing drugs like chloroquine. Defence Research Laboratory (DRL), Tezpur, under the DRDO, has identified two species of Gomphostema, which have the potential to cure both types of malaria i.e. plasmodium vivax and plasmodium falciparum. Feb 26, 2009 Vol 9, No 11 Planning commission rejects Rs 560 cr PTUF scheme for SSIs Ramesh Shankar, Mumbai The planning commission has turned down the Rs 560-crore pharmaceutical technology upgradation fund (PTUF) proposed by the department of pharmaceuticals to assist the small and medium drug manufacturing units for the technological upgradation of their manufacturing facilities in compliance with the good manufacturing practices. Mar 5, 2009 Vol 9, No 12 DGHS blacklists products of PSUs on quality standards Gireesh Babu, Mumbai The Directorate General of Health Services (DGHS), the medical stores organisation of the Union Ministry of Health and Family Welfare, has recently blacklisted or debarred some of the products from four out of the five pharma manufacturing public service undertakings (PSUs) in the country for failing to meet quality standards. Mar 12, 2009 Vol 9, No 13 DTAB recommends ban on anti-obesity drug, Rimonabant Joseph Alexander, New Delhi Drug Technical Advisory Board has recommended a ban on the use of anti-obesity drug, 'Rimonabant', in the country for the possible side effects it can cause. Mar 19, 2009 Vol 9, No 14 Pharmexcil to set up panels for various export segments Gireesh Babu, Mumbai In an effort to further improve the services to ensure service to all the sectors of the Council, the Pharmaceutical Export Promotion Council (Pharmexcil) has decided to set up separate panels of experts for various segments related to pharmaceutical exports. Apr 30, 2009 Vol 9, No 20 Pfizer sues 3 Indian cos for patent infringement of its pain drug, Lyrica Gireesh Babu, Mumbai Pfizer Inc has filed patent infringement suit against three Indian companies, namely Sun Pharma, Wockhardt Ltd and Lupin Ltd to block marketing generic equivalents to its blockbuster neuropathic pain management drug, Lyrica, in US. The lawsuit against Lupin pharma is on the allegation that the company has infringed US Patent No 6,001,876 for isobutylgaba and its derivatives for the treatment of pain issued in December 1999, Patent No 6,197,819 for gamma amino butyric acid analogs and optical isomers, issued in March 2001, and Patent No 5,563,175 GABA and L-glutamic acid analogs for anti-seizure treatment, issued in October 1996. May 7, 2009 Vol 9, No 21 Jan Aushadhi in trouble with inadequate supply of drugs Joseph Alexander, New Delhi The much-hyped Jan Aushadhi project to ensure generic drugs to the common man at affordable prices by setting up exclusive outlets in all the districts of the country has hit a roadblock, with scarcity of drugs in the stores and overall slow progress made under the ambitious scheme. May 21, 2009 Vol 9, No 23 PCI issues notices to several pharmacy colleges in MP, Rajasthan Ramesh Shankar, Mumbai The Pharmacy Council of India (PCI) has issued show cause notices to several pharmacy colleges in Madhya Pradesh and Rajasthan for flouting rules in running these institutions. The PCI action comes after the surprise inspections carried out on pharmacy colleges in Madhya Pradesh and Rajasthan in which the PCI has found serious anomalies in the pharmacy colleges of these two states. June 4, 2009 Vol 9, No 25 Chinese cos export fake drugs to Africa on 'made in India' label Joseph Alexander, New Delhi Even as India has initiated measures to counter the multinational drug companies' campaign against the Indian generic drugs in the African countries, some unscrupulous Chinese firms have posed new threat to India by producing fake drugs with label of 'made in India' and exporting them to African countries. June 11, 2009 Vol 9, No 26 New drugs may be put under mandatory lab tests by DCGI before approval Joseph Alexander, New Delhi Central drug regulatory authority is planning to start testing new drugs, especially those from the multinational companies before they launch in the country. The testing will be done in notified labs instead of current practice of relying on the claims made in the support documents submitted for marketing approval. July 2, 2009 Vol 9, No 29 K'taka DC issues order to withdraw Rimonabant from all outlets Nandita Vijay, Bangalore Karnataka drugs control department has issued a circular to stop the production and sales of Rimonabant. This order comes well before the DCGI circular to all the state departments. July 9, 2009 Vol 9, No 30 WIPO may impose 'Global Patenting System' on developing nations through PCT II BY A Special Correspondent The US, European Union and Japan are pushing a new international patent agenda through World Intellectual Property Organization on behalf of the powerful big pharma of the developed countries. WIPO, controlled by these trilaterals, is trying hard to impose a 'Global Patenting System' at the forthcoming General Assembly session of WIPO in September. The new world patent order is being sought to be introduced through a comprehensive proposal drafted by the US by floating a new Patent Cooperation Treaty, PCT II, in the General Assembly of WIPO at Geneva. The trilaterals with the support of WIPO and WHO are trying their best to get the proposal approved by the General Assembly by inducing some of developing nations. July 30, 2009 Vol 9, No 33 ICMR to fast track production of swine flu vaccine Ramesh Shankar, Mumbai Even as the country is sitting on the edge with onset of life-threatening swine flu pandemic, the Indian Council for Medical Research (ICMR) has taken the initiative to fast track the indigenous production of the H1N1 vaccine in the country. In this regard, the ICMR is presently identifying the prospective investigators to undertake phase-I and/or phase-II trials of the vaccine which is being developed by three Indian biotech companies. Aug 13, 2009 Vol 9, No 35 Central agency for buying, distributing drugs for all govt depts mooted Joseph Alexander, New Delhi The Centre is planning to set up a central procurement agency for buying and distributing medicines to all medical institutions under the government departments, with a view to bring in more transparency in such dealings. Aug 27, 2009 Vol 9, No 37 Quality mark for generics to be introduced soon Joseph Alexander, New Delhi Departments of Health and Pharmaceuticals have launched a process to introduce quality mark for the generic drugs by starting consultation with the stakeholders on the proposal. The industry, however, does not appear to be very happy with the move. Sept 3, 2009 Vol 9, No 38 DCGI to take over WHO Certification Scheme, to issue CoPP from Oct 1 Gireesh Babu, Mumbai Amidst strong protest from the pharma industry and the state drug control authorities, the DCGI has decided to centralise the issuance of Certificate of Pharmaceutical Products (CoPP) and WHO Certification Scheme for GMP for medicinal products, from October 1, 2009. Sept 10, 2009 Vol 9, No 39 Tamil Nadu colleges offering Pharm D course hike fee by 80% Peethaambaran P, Chennai The private pharmacy colleges which are conducting the integrated Pharm D course in Tamil Nadu have increased the course fee for both six-year and three- year (Post Baccalaureate) Pharm D programme by 80 to 100 per cent in this academic year. Sept 17, 2009 Vol 9, No 40 Pharma dept to take up issue of CoPP with secretary, health ministry Joseph Alexander, New Delhi Even as the Drug Controller General of India (DCGI) has taken steps to centralise the issuance of certificate of pharmaceutical product (CoPP) amid widespread resentment from the industry and the state authorities, the pharmaceutical department is also taking up the issue at the highest level to convey the feelings of the industry and solve it. Oct 15, 2009 Vol 9, No 44 Carlos Correa accuses Mashelkar for misinterpreting his quotes in revised report Ramesh Shankar, Mumbai The world renowned patent expert Carlos Correa, whose views have been widely quoted by the Mashelkar Committee to support its conclusions in the revised report, has come out in the open and complained that some of the quotes from his published article titled "Integrating Public Health Concerns into Patent Legislation in Developing Countries" have been misinterpreted by the Mashelkar Committee. Oct 15, 2009 Vol 9, No 44