NPPA revises prices of 258 formulations, 5 bulk drugs

The National Pharmaceutical Pricing Authority (NPPA) has revised the prices of 258 formulations, with nearly 70 of them including the drugs for diabetes and tuberculosis going up. The price regulator, however, decreased the prices of two bulk drugs while hiking up the rate three other bulk drugs.

According to the notification by the NPPA, the prices of 258 formulations were revised and most of the drugs gone costlier belonged to the diabetes and TB therapeutic areas. The prices of insulin-based formulations by the domestic manufactured have increased in the range of 5-18 per cent. The prices of a good number of formulations also came down while prices of over 20 drugs remained unchanged. The authority has also fixed the price fixation parameters for non-PVC bags with oxygen barrier properties. The conversion cost, packing charges, packing material cost and process loss that will be calculated for fixing the prices of such bags will now be known to the industry.

In another move, the NPPA has fixed the price of Abbott’s Gardenal Syrup 60 ml at Rs.39.60 and given the company 15 days time to revise its price tag. The epileptic drug of Abbott Healthcare was fixed on the ground that the company had increased the price of this medicine by over 10 per cent between August 2007 and August 2008. The regulations allow drug companies to increase the prices of medicines (that are normally out of price control) up to 10 per cent during a 12-month period.

The price of bulk drug Salbuamol Sulphate was brought down to Rs.3633 per kg from Rs.4478 fixed earlier in 2008. Likewise, the price of Spironolactone was reduced from Rs.29601 to Rs.28859 by the NPPA. However, in the case of Pheniramine Maleate, the price went up to Rs.1330 from Rs.1168 per kg and rate of Pyrantel Pamoate increased from Rs.1182 to Rs.1278 per kg. The price of Chlropropamide, the other bulk drug under revision, however stood unchanged at Rs.326 per kg, as per the notification.

Gatifloxacine and tegaserod banned in India

After banning a set of controversial drugs like nimesulide (for use of below 12 years of age), cisapride, phenylpropanolamine and human placenta extracts, the union health ministry has banned two more controversial drugs--- antibiotic drug gatifloxacine and chronic constipation drug tegaserod due to adverse effects of these drugs on human health.

Earlier, the Drug Controller General of India (DCGI) decided to put these controversial drugs under the radar of the DTAB in the wake of serious concerns raised by the medical experts in the country over the adverse effects of these drugs on human health. The Drugs Technical Advisory Board (DTAB), the highest decision-making body under the union health ministry on technical matters related to health issues, after taking its final call on nimesulide, phenylpropanolamine, cisapride and human placenta extracts, reviewed gatifloxacine and tegaserod.

After review, it recommended to the ministry to ban these drugs as it is “satisfied that use of the following drugs is likely to involve certain risks to human beings and whereas safer alternatives to the said drugs are available”.

A communique from the union health ministry said, “And whereas the central Government is satisfied that it is necessary and expedient to prohibit the manufacture, sale and distribution of the said drugs in public interest; Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture, sale and distribution of the following drugs with immediate effect, namely:-

(i) Gatifloxacin formulation for the systemic use in human by any route including oral and inject able; and

(ii) Tegaserod and its formulations for human use.”

Pharmaceutical Education in India at Crossroads

Indian pharmaceutical sector has grown to a world class industry during the last three decades with almost 45 per cent of its production is being exported to the US, Europe and many developing countries. The growth of this industry over the years has also pushed up the demand for quality pharmacy professionals in the country. The spurt in the number of pharmacy colleges in most parts of the country in recent years is a clear indication of this growing demand. There are more than 800 pharmacy colleges in the country at present, which was around 300 just four to five years ago. Although the number of pharmacy colleges has gone up over the years, the quality of pharmacy education is not up to the mark on account of various factors. The main reason for this situation is the shortage of competent faculty in the colleges. It is fact that a large number of the 800 pharmacy colleges is being run without adequate number of pharmacy teachers and some even do not have principals. Some of the colleges are found to be lacking even the basic infrastructure such as laboratory and equipments. As these pharmacy colleges are controlled by managements having mainly commercial interests, such lapses in maintaining standards of education are common. But, what is surprising is the indifferent attitude of All India Institute of Technical Education in periodically inspecting the colleges and taking action.Now the Pharmacy Council of India is the designated authority to ensure uniform implementation of educational standards in pharmacy colleges throughout the country by approving courses of study and examination for qualifying for registration as a pharmacist. PCI had thus issued show cause notices to several pharmacy colleges in Madhya Pradesh and Rajasthan in the past for flouting rules in running these institutions. Early this month, Pharmabiz carried a report that some of the pharmacy colleges in the country are planning to change the duration of Diploma in Pharmacy course to four years and minimum qualification for applying to the course to 10th standard from 12th with the sanction from AICTE. This is actually in contravention of the Education Regulations, 1991 (ER-91) for Diploma course in Pharmacy framed by PCI.

Now PCI has warned the colleges that in the event of any deviation from the statutory provisions with regard to admission qualification and duration of the D.Pharm course and will disqualify passed out students to be eligible for registration as a pharmacist and practise the profession under the Pharmacy Act. What is emerging from all these developments is the confusion that is being created by having dual authority in regulating pharmacy education in the country. This is not a desirable situation to have an atmosphere of uncertainty for the young pharmacists coming out of the colleges. In fact, it does not seem appropriate to have AICTE as the sanctioning authority of pharmacy colleges while PCI has to oversee the quality of pharmacy education. Central government should have thought of assigning PCI as the sole authority to regulate the pharmacy education and profession in the country.

Seminar on European patent prosecution on April 15

Academy of intellectual Property Studies (AIPS) will be organising a one-day seminar on 'European patent prosecution' on April 15 at AIPS, Mumbai. The seminar will focus on the patent claims vis-à-vis Article 19 and 34 amendments. It will focus on the amendments to Articles 19 and 34, and comment on how they influence the patent prosecution process.

Filing of patent applications at the European Patent Office (EPO) had to take into consideration a variety of amendments in the recent past. The seminar will discuss issues that are often raised while patenting certain specific types of subject matter in the pharmaceutical, chemical field, such as polymorphs and formulations, patenting of biotech inventions, etc. Strategic tips and techniques that can be employed to successfully prosecute patent applications at the EPO will also be provided at the event.

The speakers of this event are Mike Snodin, from the US & European Patent Attorney, Partner, Potter Clarkson LLP and Dr John Miles, Fellow of CIPA, European Patent Attorney, Partner, Potter Clarkson LLP.

AIPS is an institute that has been set up, in affiliation with the Indian Drug Manufacturers Association (IDMA), It aspires to be a leader in the field of IP studies, offering a mix of training and learning programmes that will enable the participants to become IPSmart.

For further details, contact: Gita Chandrashekhar on 2874 6123/6522 1097, or e-mail:gita@aips.ac.in

DCGI asks SLAs to withdraw 13 brands of ‘AZ’ with different ingredients

Following the instruction from the Drug Controller General of India (DCGI) to the State Licensing Authorities to withdraw permission to the drugs having same brand name of ‘AZ’ but with different ingredients, as many as 13 other formulations under this category have been banned in different places so far.

The DCGI, in his order dated February 2, had specifically asked the State drug controllers to ban Cetirizine, manufactured by Sienna Formulations Pvt. Limited, Vadodara, Gujarat, Albendazone, manufactured by Cure Quick Pharma, Karnal, Haryana and Azithromycin, manufactured by Eugenics, Lucknow, Uttar Pradesh.

Of the 13 formulations for which permission was withdrawn include two out of the three listed by the DCGI. ‘Zocor Dry Syrup,’ ‘Zocor Drops’ & ‘Zocor-125’ -- manufactured by Per Pharmaceuticals at Panchkula, ‘Neogest-50’ and ‘Neogest-100’ manufactured by Oscar Remedies Pvt. Ltd of Baddi, ‘Metagesic Suspension’ and ‘Metagesic Plus Syrup’ manufactured by Amree Pharmaceuticals of Karnal, ‘AZ suspension’ (Albendazole Suspension) manufactured by Cure Quick Pharmaceuticals of Karnal, ‘AZ tablets’ manufactured by R H Laboratories of Sirmour in HP. (Marketed by Cure Quick Pharma, Karnal, Haryana), ‘AZ Suspensions’ manufactured by the same R H Laboratories (Marketed by Cure Quick Pharma), ‘Calcimax’ manufactured by Alps Pharmaceuticals Pvt. Ltd of Almora (brand of Meyer Organics Pvt. Ltd.), ‘Col-Q’ manufactured by G S Pharmaceuticals Pvt. Ltd of Roorkee (brand of Blue Cross Laboratories), and ‘AZ Tablet – Cetirizine’ manufactured by Sienna Formulations Pvt. Ltd, Vadodara, Gujarat, were thus ordered to be withdrawn by the respective State authorities.

“State drug control authorities have been requested to remain vigilant while granting licenses for manufacture of drugs and withdraw permissions in cases of same brand names being used for different drugs,” according to the official sources.

Apart from ordering the withdrawal of ‘AZ’ brand which was being used for cetrizine, albendazole, azithromycin and alprazolam, the DCGI has also advised the States to check for other such cases which would create confusion at the consumers' end.

“Keeping in view of the seriousness of matter and confusion it may create at consumer end, all concerned drug controllers are requested to withdraw the permission of AZ brand on top priority and permission may be granted under any other suitable brand name. If there are other similar cases of same brand names for different drugs, they may also be withdrawn from the market in public interest to avoid confusion,” the order had said.

This was part of the measures being taken to bridle the companies from using the same popular brands even with different ingredients, which has come under the scanner of the National Pharmaceutical Pricing Authority also some time back. The NPPA had also asked the Health Ministry to amend necessary laws to check this practice, especially by some companies who would change the ingredients to dodge the price control mechanism.

KBIPER to start MBA (Pharma) for B Pharm graduates

K B Institute of Pharmaceutical Education and Research, (KBIPER) Gandhinagar, Gujarat will start a customised MBA course, exclusively for B Pharm graduates which will help the students to be more innovative in marketing, human resource, production and finance areas.

It gives a combined knowledge of pharmacy and management and also offers a dual and single specialisation in marketing, production & operations and HR areas.

“MBA is such an evergreen course with an unlimited scope. Today this course stands as an ultimate destination for pharmacy graduates. As pharmaceutical marketing is highly regulated, this course helps in moulding pharmacy students to acquire pharma marketing skills. It is very obvious that students all over the world are very crazy about pursuing management course,” said Dr Gaurang B. Shah, principal, KBIPER.

Mallika Babu, in-charge, MBA (Pharma) said, “The positive growth in pharma industry and the need of innovative people in the industry has prompted us to begin this course, which has the right blend of marketing knowledge needed by pharmaceutical companies, or the so called the Product Management Team (PMT).”

A student after passing can get to work in PMT sales, HRM, Business Development, International Marketing, Pharma Advertising, Marketing Research, Teaching profession, Regulatory affairs, project management, etc.

“The high interdependency between Pharmaceutical Industry growth and marketing management has assured more scope and good career growth and we are sincerely planning for the upgradation of this course with more practical exposure for students and also a nice opportunity to explore in the field of Pharmaceutical Management” Shah added.

The institute has got 100 per cent placement results in top Pharmaceutical Companies like GSK, Kendle, Zydus cadila, Cadila Pharmaceuticals, Torrent, Lupin labs, Jay Research Foundation, Themis lab, Alkem labs, Panchsheel organics etc. and they are looking forward for the support in future also. They arrange weekly guest lectures by eminent pharma professionals from Ranbaxy, Pfizer, Zydus, Lincoln, Quintiles etc., and also a continuous programme in this institute on every Saturday.

They have also organised workshops for MBA (Pharma) students to develop soft skills on various topics like positive attitude, mind power management, communication skills, interview skills, memory power, corporate etiquette, etc.

Seminar on medical devices in Gujarat on March 18, 19

The Drug Controller General of India (DCGI) in collaboration with World Health Organisation (WHO) is organising a two day seminar for the regulatory authorities and stakeholders of medical device industry from March 18 to 19 in Gujarat. With this seminar the DCGI aims to sensitise not only the regulatory authorities but also other stake holders about the Medical Device Regulation Bill that is expected to be passed in the Parliament.

Once the Bill on medical devices is passed by both the houses in the parliament it will be known as The Medical Device Regulation Act. This Act will focus on consolidating laws related to medical devices and to establish the medical device regulatory authority of India for establishing and maintaining a national system of controls relating to quality, safety, efficacy and availability of medical devices that are used in India.

With the enactment of the bill, the medical devices industry's long-standing demand for creating separate guidelines and definition for medical devices will be met with. H G Koshia, commissioner, FDCA informed that this seminar will focus mainly on sensitising the industry about the medical device regulation bill.

The Gujarat Food & Drugs Control Administration, (FDCA) will be co-ordinating with the DCGI and WHO to hold this event. This is the first time that the such a training seminar for medical device industry is being organised by the DCGI in the state.

Gujarat has 127 licensed medical device manufacturing units which is the largest in the country. Koshia informed that out of all the medical devices that are manufactured in the country more than 40 per cent including both new and old comes from Gujarat. Koshia points out, “Since Gujarat is considered as the hub of medical device industry it seems appropriate that this event be conducted here. This event targets at training the regulatory officials from different states and the stake holders across the country on the medical devises and the regulatory issues pertaining to it.”

He informed, that at present, medical devices is not considered as a separate entity and are treated as drugs under the Drug & Cosmetic Act with just nearly 20 notified devices regulated under this Act. Whereas there are still thousands of other devices that are outside the purview of D&C Act.

IDMA & PharmaTechnologyIndex.com to jointly organise PharmaTech Expo 2011 at Indore

Indian Drug Manufacturers' Association (IDMA), is venturing into the exhibition space with the launch of PharmaTech Expo 2011 as an initiative of celebrating Golden Jubilee year commencing January 2011. PharmaTech Expo 2011 is jointly organised with IDMA by PharmaTechnologyIndex.com, a KNS group of company and concurrent with Indiamart Indexpo at Indore, Madhya Pradesh (MP) at Lal Baugh Palace Ground, Indore from April 22 – 24, 2011.
Indore is the hub of big, medium and small pharma companies. Ranbaxy, IPCA, Plethico, Piramal, PDPL, Syncom, Lupin, Pentagon, and Advance Enzyme are some of well known manufacturers having their large production base in and around Indore. The Unichem project is now coming up in Indore in a big way as well. The event will be a great opportunity for pharma as well as machinery and equipment manufacturers to project their products during a three day events.

The main objectives of organising PharmaTech Expo 2011 in Indore, is to project the latest technological trends in pharma industry, facilities and services available, quality control and Government regulations and controls. The event will showcase the latest products, machinery, equipment developments in the industry for generating business and upgradation, and to project the brand value of organisations, joint venture firm, partnership firm, project collaborations, transfer of technology, investments and R&D.

The event will comprise of a wide range of exhibitors categories like APIs and formulations manufacturers, processing plant and machinery, packaging materials and machinery, lab equipment, instruments, lab wares, water treatment, waste management, biotechnology and CROs, intermediates manufacturers, excipients, additives, R&D, quality control etc., healthcare products, research and development and standards, environment and pollution control, technical publications, trade associations, trade promotion bodies, safety equipments and software for pharma industry and management.

IDMA-GSB announces Pharmac India 2011

Pharmac India 2011 is the second international exhibition of India’s prominent pharmaceutical and healthcare industry to be held from September 17-19 September 2011 at Gujarat University, Exhibition Hall in Ahmedabad. It aims to bring pharma manufacturers, pharma packaging material and machinery along with API’s, bio pharma with largest suppliers, distributors under one roof to discuss best ideas about the pharma industry.

The event provides a unique platform and resources to the organisations in the pharma industry with a futuristic understanding of the Indian pharma industry and market potential for their products across the world.

There is immense response received from the exhibitor. The participants of the exhibitor of the event are from all segment of the pharma industry, manufacturers of pharma formulation, active pharma ingredients (bulk drugs), pharma machinery, ayurvedic / herbal products, nutraceutical product / dietary supplements, cosmetics products, veterinary drug, medical and disposal, excipients / food additives. / natural, extracts flavours and fragrances pharma packaging material and machinery diagnostic reagents, bio pharmaceuticals, R&D/ testing labs, analytical services, contract research organisations, laboratory equipment / lab. Chemical, association / media /publications, consultant, pharma ancillary and utility suppliers.

GSK outlines new plan to drive recruitment & attract graduate talent in UK

GlaxoSmithKline (GSK) outlined new plans to encourage talented students graduating from UK universities to consider pursuing a career within the company. These measures are part of the company’s ongoing efforts, as one of the leading FTSE companies and employers in the UK, to ensure the ongoing success of the business.

Each year, GSK currently recruits between 50-100 undergraduate students from various academic disciplines into its UK Graduate Training Programmes or other roles within the company.

Successful applicants are already offered highly competitive compensation packages. However, it is anticipated that forthcoming changes to tuition fees proposed by the UK Government will result in students incurring uncapped fees of up to £27,000 for a three-year undergraduate degree course (£9,000 per year).

As a result, GSK has taken the decision to reimburse 100 per cent of uncapped tuition fees for all undergraduates recruited in the UK. These payments will be made upon the commencement of full employment and will be conditional on the employee remaining with the company for a minimum of two years.

Uncapped fees, which are subject to Parliamentary approval, are expected to come into effect from September 2012. The timeline for the introduction of this new measure by GSK will mirror the Government’s timeline, and will be offered to students incurring uncapped fees commencing in September 2012.

These changes are being introduced as part of the company’s ongoing efforts to attract, recruit and retain the best talent and reflect the changing environment in the UK for students. The company believes these measures will help ensure that GSK remains a highly desirable place for graduates to consider working upon leaving university.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

TNCDA opens Academy of Professional Excellence for grooming pharmacists

As part of its retail chain plan, the Tamil Nadu Chemists and Allied Distributors Alliance Ltd, a company formed by the Tamil Nadu Chemists and Druggists Association, will, from early next month, commence its plan of educating the member pharmacists to make them on par with international standards.TNCDA, an e affiliated body of AIOCD, has drawn up the plan with the help of the parent organization and subsequently launched an Academy for Professional Excellence which will conduct the training courses to enhance the professional competence of the drug dispensers.

The course is expected to enable the pharmacists to make them confident professionals at the counter as is the case with doctors in the healthcare system. A leading figure in the pharmacy profession and pharmaceutical trade, R Srinivasan of ‘EssenCorp’, has been made the director of the Academy.The courses, which will have five modules covering 12 days altogether, will be run based on a syllabus in which portions of other state syllabuses are also included besides a set of chapters framed by the Academy. Faculty members will be ranging from trade, manufacturing sector, regulatory bodies and doctors community. The course will enable to change the mindset of the pharmacists from a mere vendor to a true professional. The course will end with a written test and a viva-voce, and on its successful completion, the participant pharmacists will be given accreditation and a certificate, said R Srinivasan.

Sharing the details, M Arulkumar, managing director of the company, said “the chemists are now fragmented and they lack a common set of professional norms. We want them to bring into one chain and equip them professionally competent not only to become a successful trader but also to develop managerial skills of each person. Discussions are on now with the community pharmacy division of the IPA to co-ordinate the education programme.”

Vivek D Chaudhari, deputy registrar of Maharashtra state pharmacy council who has been identified by AIOCD as the master-trainer of the programme, while speaking to Pharmabiz said this is a continued education programme and in the beginning (Module A) there will have 5 days refresher classes which will help raise the confidence of the pharmacists and impart knowledge of storage conditions of medicines, general awareness about common diseases and how to handle the pharmacy with modern practices.The second Module (Patient counselling) will involve 3 days classes, but it may not be in close continuity with the first, covering five segments focusing on clinical aspects. Hypertension, angina, hyperlipidemia, asthma and diabetes are the core areas the second semester will concentrate on.

The third and the fourth modules, which will cover one day each, are dedicated to specialized areas such as dermatology and gynaecology for which competent doctors will be recruited as resource persons.The fifth module involves one day class on orthopaedics and the latest medical technologies involved in treating accidents and trauma.

A general awareness on various kinds of drugs used in ortho treatment will also be part of the training.Chaudhari said everybody knows the minimum requirement for starting a pharmacy, but nobody knows about the highest standards for maintaining a pharmacy, which will be imparted through this course.According to TNCDA Ltd, only the shareholders of the company or the members of TNCDA can become the participant for the educational program of professional excellence and a token fee for the course will be collected from the trainees. Business development, personality development, communication skill development, pharmacy development and changes in consumers’ behaviour are the areas based on which the courses are designed.Arul Kumar said all the registered owner-cum-pharmacists in the state will be encouraged to join the course. However, entry will be given to the non-registered pharmacists, if they are the owners of the pharmacy and having years of experience in the trade. He feels that the course will provide them some inputs for improving the professional standards. The members of TNCDA Ltd will retain the brand name ‘Allianz’ with their upgraded shop.In the first phase, classes will be conducted in Chennai, Madurai and Coimbatore starting with 50 participants each.