The Union health ministry will soon withdraw its ban on advertisements on emergency contraceptive pills like Unwanted-72, Option-72 and I-Pill. The ministry had imposed the ban in January last year after experts raised concern that these advertisements may promote the misuse of the pill by the young generation.
According to sources, the Drugs Technical Advisory Board (DTAB) of the union health ministry in its meeting held on October 10 has decided to allow the advertisements on emergency contraceptive pills with some riders. As per the new DTAB guidelines, a committee consisting of the principal of a reputed girls college, representatives from civil society groups and the advertising council should screen the ads and the scripts before they are on air.
Ever since the drug companies launched advertisements on emergency contraceptive pills like Unwanted-72, Option-72 and I-Pill, experts and public interest groups in the country have been raising concern that these advertisements may promote the misuse of the pill by the young generation who have started looking at the pills as a regular contraceptive method as the advertisements are said to have failed to drive home the message clearly that these pills are emergency contraceptives.
Apart from the civil society organisations, gynaecologists in the country have also been expressing concern on the misuse of the pill by the young generation. It triggered a debate in sexually conservative India with critics arguing that the easy availability of such pills would encourage promiscuity among the millions of young people. There was also criticism that the easy availability of these drugs will also promote unsafe sex among younger generation and may result in promotion of diseases like HIV/AIDS in the country.
When the public criticism reached its crescendo after the companies started airing competitive ads on these pills, the Drugs Controller General of India (DCGI) banned the advertisements on these emergency pills and left the matter to the DTAB, which is the highest authority of health experts on technical matters under the union health ministry.
Now that the DTAB has taken a final decision in favour of the pharma companies, they can start advertisements on these pills.
Source: Pharmabiz
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DCGI asks State DCs not to issue fresh licenses for FDCs with paracetamol above 325 mg
11:13 pm in DRUGS CONTROL, pharmacist by admin
The Drug Controller General of India (DCGI) has asked the state licensing authorities not to grant fresh licenses or renewals of the combination products of paracetamol, containing more than 325 mg per tablet or capsule.
The DCGI, in a notice to the zonal and sub-zonal officers of Central Drugs Standard Control Organisation (CDSCO), asked them to covey it to the respective State authorities. “The manufacturers marketing combination products having more than 325 mg of paracetamol should be asked to limit the paracetamol contents to 325 mg only in a period of three years,” it said.
The manufacturers of paracetamol combination products may also be asked to provide box warning on the label of such FDCs indicating that ‘taking more than daily dose may cause serious liver damage or allergic reactions such as swelling of the face, mouth and throat, difficulty in breathing, itching or rash,’ according to the order.
The order was issued based on the decision of the Drug Technical Advisory Board (DTAB) which agreed that as the paracetamol is known to have liver toxicity in the light of the decision taken by the US FDA, India also should limit the content of paracetamol to not more than 325 mg per tablet or capsule in the combination products in a phased manner in three years.
The proposal of limiting acetaminophen (paracetamol) was considered by the DTAB in the wake of US FDA issuing a note in January last year. The US agency asked the manufacturers of prescription combination products in USA to limit the amount of acetaminophen to 325 mg per table, citing the toxicity complications and with a view to ensuring patients safety.
The US FDA had also mentioned in the note that there was no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by the healthcare providers. “The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4000 mg within 24 hours. The elimination of higher dose prescription combination acetaminophen products will be phased out in three years and would not create shortage of pain medication,” according to the US FDA note.
Source: Pharmabiz
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Delhi Pharmaceutical Trust calls for reviewing D&C Act
3:10 pm in pharmacist by admin
Drugs and Cosmetics Act & Rules need to be modified and there is also a need to review the Schedule H drug List. The Drug Act and Rules also need to outline a clear Over- the- Counter (OTC) drug policy and also notify a ‘Pharmacist dispensing list of drugs’ and ‘Pharmacist to refer to Doctors list of diseases and medicines. These are the recommendations of the second national survey conducted by the Delhi Pharmaceutical Trust (DPT) to ascertain the ‘Professional Aspects of Pharmaceutical Service by Pharmacist.’
In reality, such a move could have a number of benefits including improving access to medicines, reducing healthcare costs, stated Dr DBA Narayana, Managing Trustee, Delhi Pharmaceutical Trust (DPT).
Healthcare delivery model needs to be reviewed at the national level to involve pharmacists fully and major reforms in the same need to be thought of. Preparation of a list of common and minor diseases and drugs for treating such conditions need to be prepared. These were the recommendations based on the national survey conducted by DPT.
The All India Quantitative Study of Consumer Perceptions, availability, role, services provided and expectations of pharmacists in India revealed that there was a definite trend in the consumers recognizing the importance of pharmacists’ role in healthcare and the trust factor has gone up from what it was a decade ago. Consumers are also getting useful information from the pharmacists about disease and drugs. Although more details on drugs from all pharmacists are insisted, consumers are clear that they do not have to pay more for such information or for the counselling provided.
The study has also proved that consumers demands are increasing to expand the services provided by the pharmacists. Further, it was also ascertained that consumers had drawn up on what they considered as common ailments which were not serious and visit pharmacists to get the medication which is being encouraged. The survey respondents accepted that many pharmacists refer the case to doctors and stay away from dispensing drugs for cases of severe chest infections, said Dr Narayana.
Nine categories which allowed DPT to comprehend the psyche of the consumers towards the pharmacy business covered asking for handling prescription, disease conditions where prescriptions are insisted on, patient counselling, usefulness of information given by chemists, willingness to pay more for getting professional information, offer brand substitution, instances of prescription being referred to the doctor by the chemist, issue of bill on purchase and confidence on pharmacist to prescribe.
The survey was conducted on 3086 respondents across the country. While Dr Narayana supervised the study, he was assisted by Kusum Devi, Nimisha Jain, T Naveen Babu and Uday Bhosale, department of marketing and management, Al Ameen College of Pharmacy in Bangalore and Asha AN. Co- investigators were Roop K Khar, department of pharmaceutical sciences, Jamia Hamdard, New Delhi, Moitreyee Manda, department of pharmacy JC Ghosh Polytechnic, Kolkata and Manjiree Gharat, KM Kundnani Pharmacy Polytechnic, Ulhasnagar, Maharashtra.
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Rajasthan govt to create 1400 posts of pharmacists in 3 months
6:56 pm in association, pharmacist by admin
Even as the Rajasthan government has launched its ambitious free medicine distribution scheme in the state, it has now decided to create 1400 permanent posts of pharmacists in the state. All these posts will be filled within three months.
According to sources, the Rajasthan government has launched the ‘Chief Minister’s Free Medicine Scheme’ under which it will distribute 400 medicines free of cost to all the patients who visit the government hospitals and medical colleges in the state. Chief Minister Asok Gehlot formally inaugurated the scheme on October 2.
Under this free medicine distribution scheme, the government has covered almost all the essential medicines, said Manoj Tongra, a legal expert and a drugs control officer in Rajasthan.
Meanwhile, Indian Pharmacist Association (IPA) has welcomed the creation of 1400 posts of pharmacists. “The state government has assured the creation and filling of 1400 permanent posts of pharmacist within three months. This is a historic event in the backdrop of the fact that there was no recruitment for the post of pharmacists in the last 25 odd years in Rajasthan,” said IPA general secretary Bhupendra Kumar.
He said that this has been possible due to the tireless and continuous efforts of IPA Rajasthan Branch. It would be a beginning of a new era for the pharmacists of Rajasthan. This decision of the state government will ultimately help in serving the most needy patients, he added.
According to Pharmacy Act 1948, no person other than a registered pharmacist shall compound, prepare, mix, or dispense any medicine on the prescription of a medical practitioner. Whoever contravenes these provisions shall be punishable with imprisonment for a term which may extend to six months, or with fine not exceeding one thousand rupees or with both.
At present work of a pharmacist in Rajasthan is done by nursing staff as there is no pharmacist recruited for dispensing of medicine. The dispensing of medicines by the professional pharmacists will further improve the overall health scenario in Rajasthan, Kumar said.
Source: Pharmabiz
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PCI to change syllabus for D. Pharm to make it healthcare oriented
11:57 pm in pharmacist, Pharmacy Council by admin
The Pharmacy Council of India (PCI), the statutory body formed to regulate the pharmacy education and practices in the country, has decided to change the syllabus for diploma in pharmacy course (D. Pharm) to make it healthcare oriented. The changed syllabus is expected to be introduced from next academic year.
Sources said that though a decision to this was taken in its Central Council Meeting held in February 2011, discussions are still on to prepare the nitty-gritties of the changes that have to be effected.
Experts said that the decision to make changes in the syllabus was taken as the PCI noticed that the syllabus, prepared way back in 1991, for the diploma course was vast, and the students were finding it difficulties to absorb the course. The changing scenario of pharmacy and current modern development makes it necessary to change the syllabus frequently.
The syllabus for each technical course needs to be updated to meet the current requirement of the country or to put new development in the new course, experts feel.
Dipankar Chakroborthy, vice president, PCI said, “We have not changed the syllabus for such a long period after it was set in 1991 and the expectation of the minimum registrable qualification of pharmacist may be changed from diploma to degree. But that decision of the central government is pending. Now it has been decided that PCI cannot wait for indefinite period for the decision of the Government to change the syllabus.”
The members of the Council has decided that the modification of the syllabus should be taken up on priority basis. While deliberating on the issue, members had pointed out that there is a need to look at the syllabus from the healthcare point of view, i.e. whether the students coming out of the institutions can act as a healthcare provider in the current healthcare set-up.
Chakroborthy informed that the present syllabus is not serving the current healthcare need. It was resolved that the diploma syllabus need to be thoroughly revised and should be made healthcare oriented.
PCI is responsible to provide a pharmacy education that focuses on the future requirements of pharmacists in the country, taking into consideration the demands of the healthcare landscape in the future. It is therefore important that the pharmacy education should be constantly revised and updated to meet the challenges.
PCI regulates the profession of pharmacy and frames education regulations prescribing the conditions to be fulfilled by the institutions seeking approval of the PCI for imparting education in pharmacy and to ensure uniform implementation of the educational standards throughout the country.
Source: Pharmabiz
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