INDIAN PHARMACIST ASSOCIATION

The All India Chemists and Distributors Federation (AICDF) has called for pharmacy bandh on August 1 in Delhi and Haryana in protest against the Union government’s decision to include Schedule HX in Drugs & Cosmetics Rules 1945 through an amendment.

Speaking to Pharmabiz over telephone from New Delhi, AICDF president  Kailash Gupta said that chemists from all the states in the country have expressed solidarity with his organization and given support for the bandh. He said the association members will assemble at Jantar Mantar at 9 am on the day and hold a protest march to Parliament. Wholesalers, retailers and pharmacists from hospital pharmacies will join the march by wearing black badges.

According to the organization, the government has decided to amend the D&C Rules to include the new schedule because of pressure from multinational companies. This will lead to acute shortage and non-availability of vital life saving drugs. The situation will also lead to corruption and black marketing.

According to Gupta 70 per cent of the total Indian population resides in rural and remote areas where basic health services are not available. By introducing this controversial schedule HX, the Health ministry is depriving the poor people from accessing life saving drugs.

Ashok Khandelwal, organizing secretary of AICDF said, part A of this schedule HX restricts the availability of 16 various life saving drugs to limited number of hospital pharmacies. It will cause harassment of patients and attendants.

Source: Pharmabiz

The Assistant Drugs Control (ADC) office at Ernakulam in Kerala has registered cases of violation against the healthcare companies, Geltec Private Limited, Bangalore and Abbott Health Care Private Limited, Mumbai for manufacturing and selling the vitamin products, Follihair tablets and Supractive capsules, without drug manufacturing licence.

Revi S Menon, the ADC at Ernakulam said these products were sold along with drugs through medical stores on prescriptions of doctors. The people were purchasing them as drugs. Drug inspectors from his office while inspecting the sales premises of Abbot Healthcare private limited in Kochi have found that the products have been sold without drug manufacturing licences.

He said the products were manufactured by Geltec Private Limited, Bangalore and marketed by Abbott Health Care Private Limited, Mumbai.

According to the ADC, both the products are combinations of vitamins, minerals and amino acids and these types of products come under price control fixed by NPPA. In order to circumvent the provisions of DPCO, Abbott was selling these products as proprietary food. The products are in pharmaceutical dosage forms- tablets and capsule, and are meant for therapeutic purposes, he said.

He said there are so many instances of drug manufacturers circumventing the provisions of the DPCO, and recently the Chemicals and Fertilizers Ministry had directed the National Pharmaceutical Pricing Authority to take up such cases with the Union health ministry to put an end to such illegal trade. He added that so many multi-vitamins are sold as food supplements and these come under DPCO and their prices are fixed by NPPA, but the manufacturers are violating the norms of the DPCO.

The retail price of Follicare tablets (10 tab) was Rs.95 and of Supractive capsules (15 cap), Rs.99. The products were distributed through pharmaceutical wholesalers, and the public got it from retail shops on prescription of doctors.

Since they were being sold without drug manufacturing licences, the inspectors seized the items from the marketing company’s store and produced before the Chief Judicial Magistrate Court at Ernakulam. The companies were given notices to stop the sale of the products in Kerala, he said.

More inspections will be conducted in the coming days in all the retail and wholesale shops to find out whether these products are marketed or not, he added.

Source: Pharmabiz

The Punjab government, on Thursday, suspended the state drug controller following reports of availability of banned drugs in shops outside National Institute of Sports, Patiala.

‘The Punjab Health Department suspended Bhag Singh, State Drug Controller with immediate effect,’ a spokesman said. ‘Bhag Singh has been suspended for negligence of duties,’ he added.

During suspension, he will report at the Punjab Health System Corporation, Mohali and cannot leave without permission.

The health department today began cancellation of licenses of chemist shops for selling banned steroids without prescription to the players of National Institute of Sports.

The health department found three shops around NIS Patiala selling banned steroids seven shops’ records were not in order.

The depatment issued show cause notice to 10 shops.

Source: DNA

The newly-constituted Drugs Technical Advisory Board (DTAB) is scheduled to meet here on June 24 and is expected to take up the issue of banning popular painkiller drug dextropropoxyphene, among other issues on agenda.

The Drug Controller General of India (DCGI) has already gathered inputs from the experts on the safety of the drug and a decision on banning the drug will be taken by the apex drug-related technical committee in its meeting. The experts are learnt to have reviewed whether the drug would be safe for human consumption. The report based on the recommendations would be presented to the DTAB, sources said.

Dextropropoxyphene is sold under popular brands like Proxyvon (Wockhart), Corbutyl (Sanofi), Parvon (Jagson Pal), Dexovon (USV) and Sudhinol (Ranbaxy). The drug is already banned in many countries including UK and US. It was alleged that the prolonged use of the drug could lead to addiction.

The Union health ministry had recently reconstituted the DTAB and it is going to be the first meeting of this highest-decision making body on the technical matters related to drugs. The term for the new body is for three years.

Sources said the DTAB is having the introductory meeting but, some issues including that of the painkiller are likely to be taken up for discussion. The DTAB, of which the Director General of Health Services (DGHS) is the ex-officio chairman, has 18 members including the DCGI.

Many other important issues like incorporating another schedule on antibiotics under the Drugs and Cosmetics Act are also pending for the consideration of the DTAB. The Ministry had already prepared the draft for the national antibiotics policy by inserting the Schedule and sent to the consideration of the Law Ministry.

Source: Pharmabiz

The Karnataka State Registered Pharmacists Association (KSRPA) is seeking the cancellation of licenses of those pharmacy counters run by unqualified staffs. In this regard, the association wants to bring amendment in the regulatory system in the pharma industry.

According to Ashokswamy Heroor, Vice president of the Federation of Chemists and Druggists of Karnataka, some of the changes in the drug law are required in order to bring better efficiency to the pharmacy business in the country. He emphasised on the changes of Drugs and Cosmetics Rules according to the modern norms.

The recruitment of qualified professionals is necessary to solve the unemployment problems in this area. The KSRPA feels that regulatory authorities have to consider those blood banks and nursing homes run by non-pharmacy chemists. “Drug license should be only issued to registered pharmacists and not to the proprietor or partner of the outlet. Registered pharmacists should be involved in the constitution as a proprietor and not as an employee. Any change in the qualified staff, fresh license has to be applied for from the drug regulatory authority, said, Ashokswamy Heroor.

Source: Indiamart

The union health ministry has finalised the 9-member expert committee to go into the issue of efficacy and safety data of human placental extract which has been banned by the government along with some other controversial drugs including the non-steroid anti-inflammatory drug nimesulide suspension, gastroprokinetic agent cisapride and decongestant drug Phenylpropanolamine (PPA) on February 10 this year.

Renowned pharmacologist Dr YK Gupta of AIIMS will head the panel. Other members of the committee include Dr Ajay Kumar of IMA, Dr Vijay Kumar of IDRI, Dr Sharma of ICMR, Dr Kotwal of AIIMS, Dr VK Tiwari, Dr VK Chakravorthy, Dr CM Sharma and Dr Lakhbir Dhaliwal of PGI, Chandigarh.

The expert panel has been constituted by the ministry on the directive of the Delhi High Court which heard a petition on April 6 by the Kolkatta-based pharma company Albert David Ltd, which was a pioneer in human placental extract therapy, for staying the government notification in which the controversial drugs were banned in the country.

Refusing to grant stay on the ministry’s notification banning the controversial drug human placental extract, the court asked the government to constitute a 9-member expert committee to go into the issue of efficacy and safety data of human placental extract. The expert committee has been asked to submit a report on the matter by May 15 this year.

The union health ministry had banned several controversial drugs including human placental extract following the Drugs Technical Advisory Board (DTAB)’s recommendation to the ministry to ban these drugs after it was found by the Board that these drugs will have adverse effects on human health. The DTAB is the highest decision-making body under the Union health ministry on technical matters.

Human placental extract was one of the controversial drugs which was under the radar of the health ministry for some time. In India, human placenta extract sold as Placentrex lotion, gel and injection is being actively promoted as a remedy for a variety of unrelated disorders such as vitiligo, wound dressing, prevention of adverse effects due to radiotherapy, fallopian tube blockage, female infertility, scarring, post-phlebitic ulcers, scars due to acne, etc.

But, that is not the case in the international market, especially in the developed countries. According to reports, all products containing extract of human placenta have been banned by the US FDA since they can transit diseases and pose serious health hazards to consumers. Placenta extract was never permitted for use as medicine in the western countries such as US, UK, Australia, Canada and European Union states due to lack of efficacy and safety data.  However, some companies in US were importing products containing human placenta as dietary supplements. However, on April 14, 2008, all products containing human placenta extracts even for use as cosmetics have been banned by the US government.

Source: Pharmabiz

The threat of a multi-drug resistant superbug looming large has forced the government to consider introduction of a separate schedule in the existing Drugs Act to regulate and check unauthorised sale of antibiotics in the country. According to the current law, schedule H of the Drugs and Cosmetics A

ct contains a list of 536 drugs which are required to be dispensed on the prescriptions of a registered medical practitioner. In order to have separate regulation to check unauthorised sale of antibiotics, a ‘Schedule H1′ may be introduced under the Drugs and Cosmetics Rules, a senior health ministry official told PTI. As part of the provisions under this new schedule, a system of colour-coding of third generation antibiotics and all newer molecules like Carbapenems (Ertapenem, Imipenem, Meropenem), Tigecycline, Daptomycin may be put in place restricting their access to only tertiary hospitals, the ministry has proposed.

Appropriate steps would also be taken to curtail the availability of fixed dose combination of antibiotics in the market. For documenting prescription patterns and establishing a monitoring system for it, consumption of various antibiotics in tertiary care public hospitals in Delhi under the central government would be studied.

The proposal for the separate provisions comes amid the fact that resistance has emerged even to newer, more potent antimicrobial agents like carbapenems.

The factors responsible for this are widespread use and availability of practically all the antimicrobials across the counter meant for human, animal and industrial consumption, the ministry says. To monitor antimicrobial resistance, it is necessary to have regulations for use and misuse of antibiotics in the country, creation of national surveillance system for antibiotic resistance, mechanism of monitoring prescription audits, regulatory provision for monitoring use of antibiotics in human, veterinary and industrial sectors and identification of specific intervention measures for rational use of antibiotics.

The health ministry has in this regard also constituted a task force to review the current situation regarding manufacture, use and misuse of antibiotics in the country, recommend the design for creation of a National Surveillance System for Antibiotic Resistance, initiate studies documenting prescription patterns and establish monitoring system for the same.

Source: Hindustan Times

The Chennai High Court on Tuesday allowed local drug-makers to sell two medicines banned by the Indian government for another four weeks, acting on a plea of small pharmaceutical companies that can now exhaust those products with their stockists and chemists.

The court order has temporarily stayed the ban on sale of nimesulide for use by children below 12 years and nasal congestion drug phenylpropanolamine (PPA) that have combined sales of about Rs 30-40 crore a year, said T S Jaishankar, chairman at industry body representing small drug-makers Confederation of Indian Pharmaceutical Industry.

However, companies cannot dispatch new batches or resume production. The association will now move the court to remove the ban on the drugs altogether.

On February 10, the government had prohibited sale and manufacture of gastrointestinal drug cisapride and medicines made from human placental extract, besides the two medicines immediately due to adverse side effects.

Source: The Economic Times

The Chief Judicial Magistrate Court of Nadapuram in Kozhikode district of Kerala has directed owner cum doctor of a hospital at Kuttiyadi and the salesman of its hospital pharmacy to pay a fine of Rs.1000 each for not abiding by the provisions of Drugs & Cosmetics Act. The order was issued on a complaint filed by Kerala State Pharmacy Council.

The owner was also ordered to pay an additional amount of Rs.1000 in the name of the hospital as an institutional punishment.

This is the first such case and punishment of its kind in the country, following surprise inspections conducted by the Council-appointed pharmacy inspectors in December last year. The verdict of the Nadapuram CJM issued on Tuesday, March 8. The hospital authorities had to pay a total fine of Rs.3000 towards penalty.

The Council has filed 26 such cases against 16 pharmacies including community and hospital pharmacies coming under four northern districts. Inspections were carried out in six pharmacy stores in Palakkadu district, two in Kozhikode, three in Thrissur and five in Malappuram. Certain pharmacies were found to have failed in complying with several provisions of the Act and hence more cases had to be registered against such stores, A Ajith Kumar, president of the pharmacy council said.

The charge levelled against KMC Hospital at Kuttiyadi in Kozhikode, for which the judgement came on Tuesday, was that it did not properly maintain the pharmacy and the drugs were dispensed not by a qualified and registered pharmacist. It is a violation of section 42 of the Act. Ajith Kumar said the hospital had not acquired sales licence from the drugs control department for running the pharmacy.

He said the D&C Act provides powers to the Council to conduct inspections to check whether the dispensaries are being run in accordance with the rules. The pharmacy inspectors have forwarded the case of violation to the drug control department also, he told this reporter.

In the telephonic conversation with Pharmabiz, the Kerala Pharmacy Council president said he formed a special squad of four pharmacy inspectors which inspected more than 150 pharmacy shops in the districts of Kozhikode, Malapuram, Palakkadu and Thrissur to check the sections 41 and 42 of the Act are followed. To their surprise, the inspectors found that a large number of pharmacy outlets, especially those attached with clinics and hospitals were not fully following the norms of D&C Act and rules. Ajith Kumar added that the inspection drive would extend to other districts also.

Apart from the president, pharmacy inspectors E V Rajendran, AK Girish, KR Abhilash and Shibu Robert were in the inspection team.

Source: Pharmabiz

DCGI finally took a decision to ban three unsafe drugs namely nimesulide, cisapride and phenylpropanolamine after several years of debate on their safety. The drugs were found to have serious side effects since early 2000 and many developed countries had already banned all of them. The Drugs Technical Advisory Board has been examining the safety profiles of the three drugs for several years and has now recommended their withdrawal from the market as their adverse effects outweigh the benefits. Among the three drugs, nimesulide was the most controversial one. The drug was banned in US, Britain, Canada, Sweden, Denmark, Australia, New Zealand, Japan and other 168 countries but it was being freely sold in India by prominent drug companies like Dr Reddy’s, Panacea Biotech and some others. Cisapride is another unsafe drug found to increase motility in the upper gastrointestinal tract of patients. The drug is also withdrawn from the markets of many countries due to its side effects. In India, the possible dangerous side effects of the drug has been brought to the notice of the Drug Controller General of India first time sometime by the Ahmedabad based Consumer Education and Research Centre in April 2000. DCGI has promptly ordered an investigation to assess the safety profile of the drug in the Indian context. The drug remained in the market almost ten years since then. PPA used in cold and cough remedies was banned in North America and western Europe some years ago. But, in India, PPA -containing cough and cold remedies such as D’Cold, Vicks Action-500, Wincold, etc are freely available in the market. Gatifloxacine, tegaserod and deanxit. are the other three drugs which are being reviewed by DTAB for their side effects. These drugs have also been banned in some of the developed countries.

Two drugs which have been banned in India last year are rosiglitazone, a high profile and widely prescribed diabetic drug and rimonabant, an anti obesity drug. Both the drugs have been withdrawn from the European markets early last year for their serious side effects. In India, the DCGI had placed rosiglitazone, under the scanner of national pharmacovigilance programme in August, 2007 in the wake of US FDA warning against the use of the drug. And it took three years for DCGI to decide whether its marketing should be allowed to be continued in the Indian market. Apart from these, quite a few drugs have been withdrawn from the markets of developed countries and India in the recent past. These actions by drug authorities establish the fact that there has been a steady rise in post marketing complications of newly approved drugs especially during the last ten years. That is what is forcing regulatory authorities to pull out more and more approved drugs from the markets. This trend shows that there is something seriously wrong with the whole system of new drug approval by world’s top regulatory bodies including in India. A stricter evaluation of safety and efficacy of any new drug is therefore called for before it is allowed for marketing in the country by DCGI to protect the public health. Marketing approval by US FDA or European drug regulatory authority should not be the criterion for approving a new drug in India any more.