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 10th Anniversary of our publication, we look at some of the exclusive stories we did this year
MCI asked to act on docs taking favours from cos
Joseph Alexander, New Delhi
Even as the Pharmaceutical Department initiative to goad pharmaceutical associations to hammer out a joint voluntary code of conduct to dissuade companies from giving freebies to the medical practitioners made no progress, the Health Ministry has asked the Medical Council of India to make the available provisions more stringent and take action against the erring doctors.
Jan 7, 2010, Vol 10, No 4
DCGI to move Supreme Court on CoPP issue
Ramesh Shankar, Mumbai
The ongoing battle between the DCGI and the industry over the issuance of CoPP is poised to take a turn for the worse as the DCGI is contemplating to move Supreme Court to find an early solution to the issue. Presently, four stay orders on the CoPP issue are pending in the Karnataka and Madras HCs for several months.
Jan 28, 2010, Vol 10, No 7
CDSCO issues norms for pharma exporters
Nandita Vijay, Bangalore
The Central Drugs Standard Control Organization (CDSCO) has issued a set of new rules to the pharma exporters in the country to be adhered to by them while doing international trade. The new rules, which contains 17 points to be strictly followed by the exporters, have been issued to the industry.
Feb 4, 2010, Vol 10, No 8
DCGI office not empowered to issue CoPP under D&C Act: TNDCOA
Peethaambaran, Chennai
The Tamil Nadu Drug Control Officers Association (TNDCOA), which in October last year had challenged the DCGI order relating to centralisation of CoPP in Madras HC, has contended in the court that the DCGI office (CDSCO) has the power to grant licences to only three items such as blood & blood products, intravenous fluids and sera & vaccine.
Feb 4, 2010, Vol 10, No 8
ICMR to hold consultations on guidelines for stem cell research
Ramesh Shankar, Mumbai
Nearly two years after issuing the guidelines for stem cell research regulation prescribing stringent procedures for sourcing and use of stem cells by research institutions in the country, the ICMR will soon embark on 'public consultations' to evolve a consensus on the document among the various stakeholders. After the elaborate consultations, the ICMR, if needed, will make the necessary amendments in the guidelines.
Feb 11, 2010, Vol 10, No 9
DTAB asks Sun Pharma to submit safety, efficacy profile of letrozole
Ramesh Shankar, Mumbai
The Drug Technical Advisory Board (DTAB) subcommittee of the Union health ministry, which is re-examining the issue of whether the controversial drug letrozole should be allowed to be marketed for sub-fertility in young menstruating women in the country, has asked the promoter of the drug, Mumbai-based Sun Pharma, to make a detailed presentation on the safety and efficacy of the drug. Besides, the subcommittee has asked for technical support from the ICMR.
Feb 25, 2010, Vol 10, No 11
Health Min decides to set up panel to revise list of essential medicines
Joseph Alexander, New Delhi
Even as the national pharmaceutical policy is still stuck in the racks, the health ministry has decided to set up an expert panel to revise the national list of essential medicines (NLEM) while the pharmaceutical department is keen to bring all 354 essential drugs in the list under price control.
Mar 4, 2010, Vol 10, No 12
DCGI rejects GSK's reply on cervical cancer ad
Ramesh Shankar, Mumbai
The DCGI has rejected GlaxoSmithKline (GSK)'s reply to the show-cause notice issued by the DCGI on GSK in December last year for launching advertisements on cervical cancer vaccine without prior approval from the DCGI.
Mar 4, 2010, Vol 10, No 12
Drug authorities begin action against ads of ayur products
Joseph Alexander, New Delhi
With the government getting tougher on the implementation of the Drugs and Magic Remedies (objectionable advertisement) Act, the drug control authorities have cancelled the licence of an ayurvedic product and put a few others under the scanner for alleged violation of the Act.
Mar 18, 2010, Vol 10, No 14
Health Min rules out immediate ban on sale of rosiglitazone
Joseph Alexander, New Delhi
The drug control authorities in India have clarified that there is no immediate plan to ban the controversial anti-diabetic drug rosiglitazone in the country in the wake of recent observations by the US FDA. Senior health ministry officials said that the ministry will wait for the decision of the DTAB in this regard before taking any action.
Mar 25, 2010, Vol 10, No 15
Embossing batch no, expiry date to be mandatory on tabs
Nandita Vijay, Bangalore
In the wake of massive recirculation of expiry drugs in the market, the union govt may make it mandatory on pharma companies to emboss batch number and expiry date on every tablet instead of present practice of printing the details with ink on each strip which can easily be erased.
Apr 15, 2010, Vol 10, No 18
Cos ask govt to set up common incinerator to destroy expired drugs
Peethaambaran, Chennai
Even as the recent expired drugs scam has put Tamil Nadu on high alert, the pharma manufacturers in the state have come up with a plan for finding a lasting solution to the present crisis in which they have proposed the establishment of a common Incinerator for destroying the expired drugs.
Apr 15, 2010, Vol 10, No 18
Agreement of EU, Central America to harm Indian exporters
Joseph Alexander, New Delhi
Even as the domestic industry and the public interest organisation are apprehensive about the proposed India-European Union free trade agreement, the EU is planning another agreement with the Central America, threatening further damage to the Indian generic exporters.
Apr 22, 2010, Vol 10, No 19
GS1 barcodes mandatory for drugs, devices procured for govt programmes
Joseph Alexander, New Delhi
As part of the efforts to further streamline the procurement and tracking of drugs, the health ministry has made barcodes using GS1 identification standards compulsory for all drugs, medical devices and other medical supplies purchased by the government through different divisions for various programmes.
May 6, 2010, Vol 10, No 21
KPPA asks Kerala govt to ban ads on drugs claiming remedies for chronic diseases
Peethaambaran, Chennai
The Kerala Private Pharmacists Association (KPPA) has demanded to the Kerala government to ban all the advertisements being sponsored by certain drug manufacturing companies to promote their products claiming best remedies for chronic diseases.
May 20, 2010, Vol 10, No 23
SevenHills Hospital set up in land for cancer hospital
Suja Nair Shirodkar, Mumbai
Its has been six days since the super speciality hospital, SevenHills Hospital, was inaugurated by president Pratibha Patil, and started its operations. Interestingly, the hospital was constructed on a plot that was alloted to the BMC for building a cancer hospital for treating poor patients at affordable charges.
July 15, 2010, Vol 10, No 31
Centre adopts 'Green Hospital' concept for all govt medical centres
Nandita Vijay, Bangalore
Union government has adopted the 'Green Hospital' concept for all its medical centres including the six AIIMS facilities coming up in the country. This is in a bid to save the rising electricity consumption at the hospitals.
July 22, 2010, Vol 10, No 32
After 8 years of initial draft, National Pharma Policy almost dead
Joseph Alexander, New Delhi
Though the government is yet to officially accept it, the much awaited pharmaceutical policy pending for the past eight years has almost been dumped, with no progress seen in this regard over one year now.
July 22, 2010, Vol 10, No 32
BCG Lab resume production after 30 months
Peethaambaran, Chennai
The BCG Vaccine Lab in Chennai has initiated steps for pilot production of Bacillus Calmette-Guerin vaccine, after a period of thirty months. On July 25, the scientists in the Lab have opened the seed lot system which was kept in the cold storage of the unit after its closure in January, 2008.
Aug 5, 2010, Vol 10, No 34
Comm Min to make barcodes compulsory for drug exports
Joseph Alexander, New Delhi
Seeking to put at rest the controversies and blown up apprehensions about the export of spurious drugs from India, the Commerce Ministry is planning to make the barcode technology compulsory for all exports of pharmaceutical products from the country.
Sept 9, 2010, Vol 10, No 39
India may face serious shortage of BCG vaccine in January next year
Peethaambaran, Chennai
India may face a serious shortage of BCG vaccines from January next year if the govt fails to take necessary steps to counter that possibility. The govt medical store depot records show that the available stocks are sufficient only till December 2010, as per information received for an RTI application by a doctor in Kerala.
Oct 21, 2010, Vol 10, No 45
DoP's new scheme offers 25% subsidy on loans for GLP compliance by SMEs
Joseph Alexander, New Delhi
With the good laboratory practices (GLP) requirements being made mandatory from November this year, the Department of Pharmaceuticals is going to introduce the new plan called “Pharmaceuticals Credit Linked Capital Subsidy Technology Upgradation Scheme” for compliance to GLP by the Small and medium Enterprises.
Oct 28, 2010, Vol 10, No 46
Govt bans rosiglitazone, asks state DCs to recall medicine from market
Ramesh Shankar, Mumbai
The Union health ministry has finally banned the manufacture and distribution of the controversial diabetes drug rosiglitazone in the country and has asked the state drug authorities to recall the medicine from the market with immediate effect. Following its ban in Europe and the restricted use in the US, the govt had suspended the import/manufacture of this medicine in the country on October 7 this year.
Nov 25, 2010, Vol 10, No 50