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The Drugs Controller General of India (DCGI) has put restrictions on the formulations of tramadol, tapentadol as wells as fixed dose combinations containing tramadol, in line with the recommendations of the new rug advisory committee as these drugs had potential for respiratory depressions and addiction.
Formulation of tramadol has been approved by the Central Drugs Standard Control Organisation (CDSCO) on January 27, 1993 for purpose of severe acute and chronic pain, diagnostic measures and surgical pain. Further the formulation of tapentadol had been approved on April 18, 2011 for relief of moderate to severe acute pain in adults 18 years of age or older.
“The NDAC (analgesics, anaesthetics and rheumatology) at its meeting held on March 22, 2013 deliberated that tramadol as well as tapentadol has high potential for respiratory depressions and addictions. The committee recommended that all preparations of tramadol as well as tapentadol should be used for severe acute pain only for a period not exceeding five days,” said a directive by the DCGI.
“You are therefore requested to direct all the manufacturers manufacturing the preparation containing tramadol or tapentadol under your jurisdiction to comply with the aforesaid indication. The labels, package inserts and other promotional literature of such products should be revised as above and submitted to the Directorate for further necessary action,” the notice sent to all the state licencing authorities said.
The DCGI, in his letter, also directed the manufacturers to communicate the changes made and compliance to the amendment to his office.
More than 100 companies, mostly lesser known entities, manufacture the painkiller tramadol, while only leading companies are selling tapentadol. However, hundreds of fixed dose combinations involving these two drugs are in the market.
The European Medicines Agency (EMA) has recommended restricting the use of methysergide due to concerns that it could cause fibrosis, a condition in which fibrous (scar) tissue accumulates in the body’s organs potentially damaging them.
Methysergide medicines are now only to be used for preventing severe intractable migraines and cluster headaches (a type of severe, recurring headache on one side of the head, usually around the eye) when standard medicines have failed.
In addition, treatment should only be started and supervised by a specialist doctor with experience in treating migraine and cluster headaches. Patients should also be screened for fibrosis at the start of treatment and should have additional screenings every six months. Treatment must be discontinued if symptoms of fibrosis occur.
The Agency’s Committee for Medicinal Products for Human Use (CHMP), which conducted the review, noted that these recommendations were necessary due to the reports of fibrosis seen with methysergide and other medicines of the same class (ergot derivatives). The symptoms of fibrosis often take some time to appear and without screening the diagnosis may come too late to prevent severe (and potentially life-threatening) damage to organs.
Regarding the benefits, the Committee noted that there is some evidence of a clinically relevant effect of methysergide when used for prevention in patients who regularly get migraines and cluster headaches and for whom treatment options are limited. Methysergide has also been used for treating diarrhoea caused by carcinoid disease (a slow-growing tumour that commonly affects the gut). However, there were no data to support this use and Methysergide should therefore no longer be used in carcinoid disease.
The prescribing information for physicians and information in the patients’ information leaflet will be updated. The CHMP recommendations will now be forwarded to the European Commission, which will issue a final legally-binding decision.
The Agency’s recommendations are based on available data on the benefits and risks of methysergide, from clinical studies, post-marketing safety reports and the scientific literature. Based on these data a potential causal association between methysergide and fibrosis seems likely. The mechanism by which methysergide could cause fibrosis through serotoninergic-receptor activation is widely described in the literature.
The much delayed elections to 16-member Committee of Administration (CoA) of the Pharmaceuticals Export Promotion Council of India (Pharmexcil), will be held between 22-24th of March 2014.
Before that the e-mail ballots will be sent to all the enrolled candidates on 21st March 2014. The candidates will be allowed to vote using electronic voting system till 5.30 pm on 24th March and the counting and declaration of results will also be completed by evening on the same day. Interested members from the pharma, biotech and other related sectors should file their nomination on or before 14th March 2014. On the same day the council will announce the names of the contesting candidates. Last date for withdraw of nominations is 20th March 2014.
In fact the council was expected to conduct elections for its administrative body in August 2013, but as the Ministry of Commerce intervened and suggested several changes in the composition of CoA and criteria of elections, the council postponed the election schedule to December 2013.
But again the changes in the rules for elections and broadening of CoA required some amendments to the Articles of Association, because of which the council had sought some time. Now in a recently held general meeting on 12-02-2014 the council has approved all the amendments and has finally notified the election schedule in March 2014.
“As suggested by the Commerce department, the Pharmexcil has made necessary changes accordingly and all the statutory requirements are in place to hold the elections during March 2014. We invite all the members’ pharma and biotechnology to enrol as ordinary members and participate in the voting to chose the right candidates for CoA,” informed Raghuveer kini, Executive Director, pharmexcil.
It is expected that the elections for entire CoA having 16 seats will be held in the 3rd or 4th week of March 2014. So far council has already enrolled 600 members as voters or contestants in the elections. The enrolment process is still continuing and the council is seeking more members from the pharma, biotechnology and Ayush to register and become eligible voters for electing CoA members.
The main eligibility criteria for the companies to become ‘Ordinary Member” is that, the members should have at least completed three years membership with the Council and should have been renewed their membership for the year 2013-14. Moreover the member companies should also have had at least Rs. 25 lakh as its export turnover and in case of SSI units, an export turnover of Rs. 10 lakhs is mandatory to be registered. Elections will be held through electronic voting system, for which the members should send in their authorized e-mail IDs to whom electronic voting link will be sent for exercising voting.
The members can enroll themselves online as ordinary members till 10th March 2014.
With a view to ensure that the Indian eHealth initiative is on par with the international standards, healthcare experts want the government to take pro active measures towards adopting and strengthening its eHealth programme by focusing on the need for setting up standards and interoperability for the same. Experts feel that it is high time for the government to formulate strong set of guidelines for eHealth programme, focused on providing technology driven healthcare services to larger spectrum of patients across the country.
Interestingly, earlier this month, the World Health Organization (WHO) had a joint inter-ministerial policy dialogue on eHealth standardisation and interoperability at its headquarters in Geneva. Wherein, the United Nations (UN) agency for health, and WHO equivocally recognised the strategic role of information and communication technologies (ICTs) and medical devices in support of health systems to achieve universal health coverage in countries.
Rajendra Pratap Gupta , chairman , of Continua Health Alliance -IWG who represented India at this international forum stressed that implementing health data standards to achieve interoperability is fundamental to harnessing the full potential of ICTs and medical devices in support of health systems in countries. He stressed that since India is in its nascent stage of adopting eHealth imitative, it would be imperative and more logical to adopt interoperability at at earlier stage when its easy to adopt, especially since it is already an accepted set of standards globally.
Gupta asserted,“Interoperability is a patient safety issue and any compromise will impact the diagnosis and treatment or both, putting the patients at risk. Today there is an urgent need for full adoption of standards for interoperability at national and sub-national levels. To attain this, it is essential for the government to first understand the key policy issues in eHealth standardisation and interoperability and also expert insights on how to overcome regulatory and administrative barriers in standards adoption.”
He further pointed out that now that the Continua Health Alliance guidelines have been accepted by ITU as the interoperability standard for eHealth globally, it would be the right step if the MOHFW also to accept the same, taking India at par with the global standards on interoperability. “Most importantly, we strongly feel that all medical devices and softwares must address this issue before getting into the solution development. If they fail to do so, and adopt these standards in the later stage of product or solution development, it would mean a lot of work, loss of time and additional investment for redoing the systems again,” Gupta added.
Continua Health Alliance (Continua), an international not-for-profit industry group, is the leading organisation convening global technology industry standards to develop end-to-end, plug-and-play connectivity for personal connected health .