Formula 1 technology in drug trials

Doctors are using Formula 1 technology to test the effectiveness of experimental medicines.

Smart sensors used by McLaren to track the performance of their cars on the track are being used for the first time in clinical trials of new drugs.

GlaxoSmithKline (GSK) hopes that by precisely tracking the movements of patients they will get earlier feedback on whether a drug helps to get them back on their feet.
Currently doctors try to estimate a patient's response to a drug by asking how far and how often they walk.
But sensors that are taped to the neck can monitor patients day and night, providing a far more objective - and accurate - measure of activity.

The accelerometer gives detailed data on a patient's physical activity

Dr Caroline Hargrove, technical director at McLaren Applied Technologies, is adapting the sensors and the software used to analyse the data for human use.
"Rather than how fast you have gone round a lap, it's how many minutes of walking you have done," she said.
"A simple, small sensor gives you so much context to go on. It captures something quite subjective - the level of activity you do.
"It's something difficult to get out of people."
Sky News was allowed to test one of the sensors over several days.

McLaren's Dr Hargrove is adapting the F1 technology for a new purpose

The 3D accelerometer is so accurate that scientists were able to differentiate periods of relative inactivity while working, from general movements around a home or office.
They can even tell how often people move while in bed to give an indication of their sleep quality.
GSK is using the sensors to in drug trials on patients who have rheumatoid arthritis or have suffered a stroke.

The data can even give an idea of the quality of someone's sleep

Dr Ravi Rao, a consultant rheumatologist and medicines development leader at the company, said the data can be analysed to determine the duration of an arthritis patient's stiffness in the morning.
"These quality of life measures, in terms of how a patient is functioning with a disease, are incredibly important - more important sometimes than a blood test or a physical examination."
The pharmaceutical company hopes the technology will speed up drug development.
Currently, it takes 10 years and hundreds of millions of pounds for a medicine to go from lab bench to clinic.

The sensors can help people who have arthiritis, says GSK's Dr Rao

Dr Steve Mayhew, leading GSK's partnership with McLaren, said: "By getting an early understanding of whether our medicine is behaving as we expect, it allows us to make a decision on whether to continue to develop it.

"Crucially we won't recruit patients to an experimental study where we don't think there will be any benefit to them."

from: sky news

Pondicherry accounts for highest number of FDCs approved without prior permission from DCGI

Pondicherry, which has been recently in the news regarding violation of 122E Drug & Cosmetic Rules, was found to have approved the highest number of fixed dose combinations without the prior approval of the Drug Controller General of India (DCGI) in the past.

According to the information gathered by the Union Health Ministry, of the total 23 such cases of approvals to FDCs, Pondicherry has reported as many as 8 cases. The Centre had fixed October 1, 2012 as the cut-off date for implementing the rule to get prior permission by the state authorities from the DCGI for approving FDCs.

After Pondicherry, Uttarakhand was found to have sanctioned five FDCs while Maharashtra, Madhya Pradesh and Himachal Pradesh reported two each cases. Goa, Tamil Nadu, Haryana and Union Territory of Daman and Diu sanctioned one FDC each. Out of these, 11 were approved during 2011 and the rest during 2012, as per the information.

“As many as 23 cases of new FDCs , considered as new drugs, were also found to be licenced by State Licensing Authorities (SLAs) without approval of the DCGI . In all such cases, the office of DCG (I) took up the matter with respective SLAs for necessary action,” according to official sources.

“The State Drug Controllers have been requested in the Drugs Consultative Committee meeting to ensure that new drugs and FDCs are not permitted without approval from the office of DCG (I) and the drugs prohibited by the Central Government are withdrawn from the market with immediate effect. States have also been advised to strengthen their infrastructure for better enforcement and develop vigilance mechanism over the drugs moving in the market,” sources added.

On October 1, 2012, the Central Government issued statutory directions under Section 33 P of the Drugs and Cosmetics Act, 1940 to all State/UT Governments to instruct their respective drug licensing authorities to abide by the provisions prescribed under the Drugs and Cosmetics Rules for grant of manufacturing licenses for the drugs falling under the definition of the term “new drug” and not to grant licenses for manufacture for sale or for distribution or for export of such new drugs, except in accordance with the procedure laid down under the said rules without prior approval of the DCG (I).

Recently, the health secretary to the government of Pondicherry had issued show-cause notices to 20 pharmaceutical manufacturing companies operating in region for violation of provision of 122E of the Drugs & Cosmetics Rules following a probe by the Government on the alleged nexus between a former official and a section of the manufacturers.

Source: Pharmabiz

DCGI office Organizational Structure

Here is the Organizational Structure of the Drugs Controller General of India office.



 

Director General (DG) of Pharmaceutical Export Promotion Council of India (Pharmexcil)

The Pharmaceutical Export Promotion Council of India (Pharmexcil) has created a new post of Director General (DG) and appointed Dr P V Appaji as the new DG of the Council. Prior to this appointment, Dr Appaji had served as Executive Director (ED) of the Council for the past 8 years since 2004.

Raghuveer Kini has been appointed as the next Executive Director of the council. Earlier, Kini had served the council in the capacity of additional executive director since its inception. He is regarded as a well experienced and dynamic personality who is fully aware of all the activities of the Council.

Earlier, the Council did not have the Director General post, but as part of its internal review, the administration had decided to create the new post to forgo the growing work pressure on the ED. At the same time, it had also decided to honour the exemplary services of Dr Appaji and promote him to the next higher level as the DG.

The new DG will now focus his concentration on the policy matters of the council. Apart from devising policies for pharmaceutical export promotion, the DG will also supervise the over all functioning of the council. “Now, my job will be to focus more on policy matters. In the next one to two months we will organize a meeting and come out with a new frame work for our export activities,” said Dr Appaji.

On the upcoming activities of the council, Dr Appaji said, “As of now we are concentrating on organizing India Pavilion at 15th South East Asia Healthcare & Pharma Show in Malaysia. The event will be held from April 17-19, 2012. Apart from this, we are also attending the interactive meeting with duty drawback committee which is going to be held on April 12. We will put forth our views and suggestions to the committee,” said the new DG.

Since inception in 2003 the Council had been striving hard to promote the Indian pharmaceutical sector to the world markets. In its endeavour it had organized many national and international events, seminars and exhibitions. It had facilitated networking with world’s leading players to the Indian manufactures and had played a catalytic role in framing viable export policies and helped the government to understand industry point of view in resolving various issues pertaining to export regulations.

Resistance to malaria drug rings alarm bells

 Resistance to anti-malarial drug artemisinin in western Thailand is sending alarm bells ringing among global experts involved in controlling and eliminating the scrouge worldwide, a new study says.

Another study, also by Texas Biomedical Research Institute and their Thai collaborators has indentified a major region of the malaria parasite genome tied to artemisinin resistance, raising hope that there may soon be effective molecular markers for monitoring the spread of resistance.

Malaria killed 655,000 people or over one per minute in 2010. Malaria deaths have declined by 30 per cent over the past decade, because of effective control using treatment with combination therapies containing artemisinin, a plant-derived antimalarial drug developed in China, the journal Lancet reported.

Patients infected with malaria parasites who respond poorly to treatment have been observed in Cambodia, bringing forth a coordinated World Health Organization effort to eliminate the disease in this region, said a university statement.

From 2001 until 2010, the Texas Biomed team and collaborators studied 3,202 patients in clinics in Northwestern Thailand, 500 miles from the Cambodian focus, according to the journal Lancet.

Researchers observed a dramatic decline in the drug potency over that period. Further, by measuring drug potency in patients infected with genetically identical malaria parasites, they were able to show that the decline in potency results from the spread of resistance genes.

“Spread of drug resistant malaria parasites within Southeast Asia and overspill into sub-Saharan Africa, where most malaria deaths occur, would be a public health disaster resulting in millions of deaths,” said Texas Biomed’s Standwell Nkhoma, who led the study.

“The problem we have is that treatment with artemisinin-based drugs will promote spread of resistance, but there are no viable alternative treatment options in Southeast Asia,” said Nkhoma.

“Our group wanted to understand what genetic changes have occurred in these parasites,” said Texas Biomed’s Ian Cheeseman, who led the companion study, the journal Science reported.

“This study narrows the search to a region of the parasite genome containing around 10 genes. We haven’t yet found the precise changes involved, but we are getting close,” said Cheeseman.

Source: The Hindu

98 New Drug Inspectors to be recruited in Tamilnadu

As part of strengthening the department of drugs control for better enforcement of drug acts, the government of Tamil Nadu has decided to fill up vacancies of 98 drug inspectors against a sanctioned strength of 146 posts.

The state public service commission has called for applications from graduates in pharmacy for written test and interview and the process will be completed by June this year, it is learnt.

Along with the recruitment of new drug inspectors, the government will also fill up 23 vacancies of junior analysts in the state drug testing laboratory, for that too, the PSC has invited applications. Graduates with B Pharm or B Sc qualifications can apply for the posts.

The last time recruitment of drug inspectors in the department was taken place in January 2010, when 23 vacancies were filled up. It was after a period of ten years that appointments were held, still vacancies were existing. At present the Tamil Nadu drugs control department has only 48 drug inspectors for inspection and sample collections in the hospital pharmacies, retail and wholesale shops and manufacturing companies covering 32 revenue districts.

Currently, due to shortage of staff, the workload on the drug inspectors is quite heavy affecting the work efficiency. As per rules one inspector has to inspect 50 retail outlets and an equal number of wholesale stores in a month and should collect seven samples for testing. In most of the months the routine work cannot be completely fulfilled with the limited staff. Since the majority of drug inspectors are females and working in villages, they cannot fulfill the target always.

As far as the drug testing laboratory is concerned, due to lack of technical staff and analysts the test reports are always delayed. So the drug inspectors are collecting samples of long expiry drugs. If short expiry samples are taken and found in the lab test as ‘not of standard quality’, the department will not get sufficient time to hold investigation and further action. So, all the drug inspectors are collecting long expiry samples, sources from the traders’ community maintained.

To solve all these problems, the present drug controller has submitted a project, including new recruitment, to the government which later approved it. The drug inspectors complain that inadequacy of conveyance facility is becoming a major challenge to their work.

Source: Pharmabiz

First generic Lexapro to treat depression and anxiety disorder

On March 14, 2012, the U.S. Food and Drug Administration approved the first generic Lexapro (escitalopram tablets) to treat both depression and generalized anxiety disorder in adults.

Depression is characterized by symptoms that interfere with a person's ability to work, sleep, study, eat, and enjoy once-pleasurable activities. Episodes of depression often recur throughout a person's lifetime.

Signs and symptoms of major depression include: depressed mood, loss of interest in usual activities, significant change in weight or appetite, insomnia or excessive sleeping (hypersomnia), restlessness/pacing (psychomotor agitation), increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicide attempts or thoughts of suicide.

People with generalized anxiety disorder (GAD) are filled with exaggerated worry and tension, even though there is little or nothing to provoke it. They anticipate disaster and are overly concerned about health issues, money, family problems, or difficulties at work. GAD is diagnosed when a person worries excessively about a variety of everyday problems for at least six months. People with GAD can’t relax, startle easily, and have difficulty concentrating.

Source: FDA

FDA Guidance Documents Update

The US FDA have released the following guidance documents recently.


1. Guidance for Sponsors, Investigators, and Institutional Review Boards: Questions and Answers on Informed Consent Elements,21 CFR § 50.25(c) (Small Entity Compliance Guide)

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf

2. Guidance for IRBs,Clinical Investigators,and Sponsors: IRB Continuing Review After Clinical Investigation Approval

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294558.pdf

3. Guidance for Industry and FDA Staff: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND, Frequently Asked Questions

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.pdf

4. Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers, Final Guidance

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM295372.pdf

Virtual Clinical Trials - Pfizer leads the race

I was very much interested to know what this is all about when I saw the Program of "Partnerships in clinical trials" conference that started yesterday at The Marriot World Cener, Orlando, FL, USA. Really interesting idea.

How about running clinical trials at a subject's home ?! Yes, that is all about Virtual Clinical Trials.

Pfizer have become the forerunner of this new approach in clinical trials. They have decided to leverage the advantages that the digital world provides to overcome the difficulties faced while conducting a usual clinical trial. Difficulties range from finance, logistics, partnering, enrolling patients, labs, ethical and legal issues, storage, dispensing of IP, etc. in a clinical trial. If not all the difficulties, many of those seems to be overcome in virtualtrials (which has limitations of its own!)

Pfizer began the first ever virtual clinical trial, REMOTE (Research on Electronic Monitoring of OAB Treatment Experience) to determine whether the results of the pilot ‘virtual trial’ can replicate those of a previously completed Phase IV study with tolterodine tartrate (Detrol LA)

• 600 patients from around 10 states across the US
• Screening is online
• Consent online using video/multimedia
• Subjects will manage their own trial activity and report results directly to a trial investigator,
• Study drugs will be shipped to the subjects' homes rather than to study sites
• Study participants will get $25 for each online assessment and/or laboratory visit completed, up to a total of US$175.
• No study site visits

Potential advantages would be real time and reliable data collection, a lot of time, money and effort saved. A lot of paperwork is eliminated and of course audit findings will be clear.

“Studies like REMOTE could make biomedical science much more accessible to people who have long been excluded from or under-represented in clinical trials,” said Dr Freda Lewis-Hall, executive vice president and Chief Medical Officer of Pfizer.

But to train almost 600 people on the systems to use, procedures to follow will be tough job for Pfizer and the advent of technology is itself a limitation of its use. And the main disadvantage of this would be that this system is more applicable to conditions where there are a lot of patient reported outcomes and those that does not involve any complex diagnostic or treatment procedures. That again raises a concern of the scalability of this system. Moreover, I cannot imagine something like this to be a reality (at least in half a decade) in an African country or a developing nation where the cost of healthcare is still a economical burden on the patients.

Least, this does spice up the clinical trial experience for trial personnel and subjects who are tech savvy!

Here is the program at "Partnerships in Clinical Trials" confernence. No wonder Pfizer dominates this  session. They lead the race with no visible competitors.

Monday, March 5, 2012—Executive Summit Day and General Session Kick-Off 9:30 Chairperson's Opening Remarks,PFIZER INC. 9:45 Virtual Trials— what are They? - PFIZER INC. 1030 Making a Study Different: What is Truly Innovative About the Virtual Trial Approach? - GENENTECH (ROCHE) 11:00 Break 11:30 Case Study: New Results From Pfizer's Mobile- Powered Virtual Clinical Trial Outsourcing Pilot Program, PFIZER INC. 12:30 Lunch 1:30 Assess the Legal Risks and Considerations of Virtual Trials, GORDON & REES LLP. 2:15 Examine Collaboration of Technology Companies Needed to Support the Virtual Trial Model 2:45 Industry Collaboration: How Should We Approach and Work With the FDA to Create a Regulatory Process for Virtual Trials? - PFIZER INC. AND JANSSEN 3:30 Summits End

Counterfeit drugs - A global threat

A recent editorial on "The Lancet" called for strengthening the fight against counterfeit drugs. This call comes right after the US FDA have warned that 19 medical practices had bought counterfeit versions of the anti-cancer drug bevacizumab (Avastin) of Roche from an overseas supplier. This was not the first alarm over counterfeit drugs this year. 

Counterfeit drugs apart from causing serious adverse effects lack the efficacy that of the genuine drug. Counterfeit anti-infective drugs might also increase the risks of drug resistance. Counterfeit drugs are found across all economic situations - in developing and developed nations. The category of drugs might differ though. In 2009, there were 34 million fake tablets (including antibiotics, cancer treatments, and sildenafil citrate (Viagra)) in seized just 2 months.

The article quoted the statement from WHO, “counterfeit drugs may erode public confidence in health care systems, health care professionals, the suppliers and sellers of genuine drugs, the pharmaceutical industry and national Drug Regulatory Authorities”. 

In 2006, WHO created IMPACT (International Medical Products Anti-Counterfeiting Taskforce) a global initiative to curb counterfeit drug malaise. But some NGOs and Indian and Brazilian Governments have opposed the work of IMPACT. The principal reason is they believe it would confuse quality and intellectual property rights issues and thus undermine access to legitimate and much lower-cost generic medicines consumed mostly in poor areas. Although enforcement of trademarks is often one way that dangerous fake medicines are stopped, overzealous interpretation of intellectual property laws can reduce access to good medicines. Kenya's Anti-Counterfeit Act, enacted in 2009, has been criticised for not clearly distinguishing the difference between generic and counterfeit drugs. The Act was challenged as a violation of the right to life by three patients with HIV/AIDS, because they were denied affordable generic medicines after the enforcement of the law.

The Lancet, Volume 379, Issue 9817, Page 685, 25 February 2012
doi:10.1016/S0140-6736(12)60289-X

British Pharmacopoeia 2012

The British Pharmacopoeia (BP) 2012 is the leading collection of standards for UK medicinal products and pharmaceutical substances. Produced by the British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare products Regulatory Agency, the BP makes an important contribution to public health by setting publicly available standards for the quality of medicines.

Used in over 100 countries, the BP remains an essential reference for all individuals and organisations working within pharmaceutical research and development, manufacture and testing across the globe.

New for 2012

• Legally effective from 1 January 2012
• 35 new BP monographs for formulated preparations
• Additional standards for widely used unlicensed medicines
• European Pharmacopoeia 7th edition material up to and including Supplement 7.2
• Free in-year updates in January, April and July to harmonise with the European Pharmacopoeia

The BP 2012 package comprises five volumes of the British Pharmacopoeia 2012 and a single volume of the British Pharmacopoeia (Veterinary) 2012, along with a fully searchable CD-ROM and online access to provide you with flexible resources.

Click here to find out more about the contents of the BP 2012 and to download the index.

Plea to address span of control issues in new drug policy

The Indian Pharmaceutical Alliance (IPA) has a few issues relating to the ‘span of control' in the draft National Pharmaceutical Policy (NPP) 2011.

IPA Secretary General D. G. Shah said the draft policy stated that the ‘span of control' was likely to go up to 60 per cent. The prices of almost half the ‘essential medicines' will be reduced by 5-80 per cent and the other half by 5 per cent.

The IPA estimates that domestic price reductions alone will result in about Rs 3,000 crore loss in sales to the domestic industry where the players have contributed 95 per cent of increase in gross fixed assets and 77 per cent of R&D expenditure in the industry in the last 15 years.

However, IMS Health data show that the ‘span of control' can effectively be as high as 75 per cent — more than four times the current ‘span of control' and more than twice the ‘span of control' as per the National List of Essential Medicines (NLEM), 2011.

It will, in effect, bring an additional 1,154 drugs and 6,441 formulations under price control as against the Drug Price Control Order (DPCO), 1995, of 38 drugs and 800 formulations with an 18 per cent ‘span of control'. “The proposed additions will enlarge the scope of price regulation by over eight times the current volume to about 68,000 packs, making the task unwieldy and ineffective. ,'' said Mr. Shah.

With an enlarged ‘span of control', the domestic manufacturers can shift investment outside India as they have facilities all over the globe. “Importantly,'' according to Mr. Shah, “large domestic companies, which contribute around 81 per cent of total pharma exports, earn an average 50 per cent of their revenues from exports. The price reductions in the country will have an impact on export price realisation also as all importing countries check domestic prices.''

The IPA has suggested that to ensure a sustainable supply of essential medicines, the policy should stay with the NLEM 2011 list, which covers 348 drugs and 654 formulations with a ‘span of control' of 30 per cent.

In a bid to balance consumer interest and the pharmaceutical industry's growth, the government is considering plans to increase its procurement of essential medicines by 7-8 times from the domestic industry for supply to the weaker sections of the society.

The IPA Secretary General felt the success of such a programme would hinge on the industry being able to produce huge volumes and also its ability to absorb the costs of supplying the enhanced volumes at heavily discounted rates.

Source: The Hindu

IPC starts supply of IP reference substances to state, central drug testing labs

The Indian Pharmacopoeia Commission (IPC) for the first time provided around 50 IP reference substances to different state and central drug testing laboratories across the country. With this the Indian Pharmacopoeia started supplying India's own reference substances to the drug testing labs.

Dr G N Singh, secretary cum scientific director of IPC, informed, “By providing these references substances we would help in asserting the quality of the medicines that is moving in the market. We aim to bring in more IP reference substance for the industry in the coming four to five years.”

IPC supplied the reference substances to the drug laboratories late last month following the demands made by the government analysts from state and central drug testing laboratories. Apart from the demand for requisite IP reference substances the analysts also demanded for availability of hard copy of the IP 2010.

These demands where made by the government analysts during an interactive meeting that was organised by IPC in collaboration with WHO and CDSCO in Mumbai in May this year.

According to Dr Singh, “Through this meeting our main focus was to understand the challenges and issues faced by the drug analyst in the country. And the steps that we took by providing these IP reference substance to them is just a start on how we are trying to meet their demands.”

K Chandramouli, secretary Health & Family Welfare and chairman, IPC recently in his visit to the IPC ensured that he would expedite the process to ensure that the three main demands made by the commission to have adequate lab space, latest instruments and competent work force would soon be addressed.

Among the other major developments, IPC has put the National Formulary of India (NFI) in the CD format and is soon planning to put its contents in the mobile form as well for easy accessibility of the same to the doctors, chemists and nurses.

The selection of drugs for inclusion in the NFI has been made taking into consideration the relative advantages and disadvantages of the various drugs used, the extent of their use in current medical practice and their availability in the country.

It is a publication that contains guidelines on right dosage of medicines for drug prescriber's. NFI is essentially meant for the guidance of the members of the medical profession, medical students, nurses and pharmacists working in hospitals and in sales establishments.

NPPA to launch SMS helpline to give options to consumers for buying cheaper brands

The Department of Pharmaceuticals (DoP) in collaboration with the National Pharmaceutical Pricing Authority (NPPA) will soon roll out an SMS-based helpline to help the consumers to choose the cheapest available drug.

The NPPA has launched the exercise for this ambitious programme, which has been mooted for long to make available the affordable drugs to the consumers and thereby indirectly influencing the market prices through transparent competition.

The NPPA has called for expression of interests from the interested agencies to set up and run the helpline. The consumer can send the brand name of a prescribed drug in text message and will get a list of brands of the same medicine along with their prices for choosing the cheapest brand.

The move is initiated after the NPPA had found that there were huge differences in the prices of different brands of the same medicines. In some cases, expensive brands are ten times higher than the cheapest available alternative brand of the same medicine. And the consumers do not have options, as they are not aware of the brands other than what is prescribed by the doctors. This SMS service is aimed at helping out the consumer on this count, sources said.

“In order to enable the consumers to know the latest market price of the medicines through SMS, NPPA intends to start all India SMS helpline service for consumers. Expression of Interest (EoI) is invited from eligible companies/firms/agencies having sufficient experience, infrastructure and access to MRP of all the medicines available and sold in various parts of India,” according to the notification by the NPPA.

“To provide instant information through SMS (in 160 characters) reply on the latest market price of various generic and branded medicines of the same salt available in the area of the queerest on receipt of SMS query from the consumers. If the query is for the price of a specific brand the SMS reply be for the latest MRP of the said brand in that area. In case the query is for the cheapest medicines without specifying any name subject to space availability the service provider will provide at least five cheapest prices of generic medicines and five cheapest prices of branded medicines,” according to the scope of work specified in the notice.

The company/firm/agency should have three years experience of providing this type of services. The company/firm/agency should have access to latest market price of all the generic and branded medicines available and sold in various parts of the country including in the remote areas. The company/firm/agency should have the ability to track and update the new generic and branded medicines prices at least on quarterly basis to give the most relevant SMS reply considering the latest updated MRP prevailing in the area of the queerest, it said.

Centre asks States to follow TN model for procuring drugs for public health programmes

The Union Health Ministry has asked the States to follow the model of Tamil Nadu for purchase of drugs for public health programmes, with a view to ensure transparency, availability, and distribution as the model has proved to be very effective.

“There is also great merit in making bulk purchase of drugs through a specialised agency. This not only ensures better quality but also reduces the prices. States may like to examine the Tamil Nadu Medical Services Corporation model set up by the Government of Tamil Nadu for the purchase of drugs for public health programmes,” the Health Ministry told the States, at a recent meeting of Health Secretaries here.

The Centre also wanted the States to set up special courts to tackle the spurious drugs cases. “It is also important that once the drug samples fail quality and safety standards, prosecutions are launched and culprits are booked quickly. There is need to set up Special Courts to try prosecution cases under the Drugs & Cosmetics Act 1940. Many have already designated Special Courts for such trails while others also should act on a priority basis,” the meeting was told.

“While promoting the generic drugs, it is important that a rational Fixed Dose Combinations (FDC) are weeded out from the market. This not only enhances the price of the drug but also leads to several other health consequences including drug resistance. While granting licenses for manufacture of FDCs, State Drug Regulators must be very careful regarding efficacy of such drugs,” the written brief by the Centre said.

Tamil Nadu Medical Services Corporation Ltd was set up with the primary objective of ensuring ready availability of all essential drugs and medicines in the Govt Medical Institutions throughout the State by adopting a streamlined procedure for their procurement, storage and distribution. TNMSC aim is to make the drugs and materials available to the poorest of the poor and “Service to the Public.”

It handles procurement, testing, storage and distribution of medicines, surgicals, kits and reagents to the Government Medical Institutions of the State. It finalises rate contract every two years for various frequently used surgical appliances, Instruments for direct procurement by the medical institutions in the State.

Recently, the public interest organisations have also called for adopting the time-tested TN model across the country. The Jan Arogya Abhiyaan (JAA), a network of NGOs working on health issues in Maharashtra, urged the State Government to implement it. Kerala has adopted it and other states like Rajasthan and Bihar are also in the process.

Source: Pharmabiz

Dr. Surinder Singh to continue as DCGI Until October

Much to the relief of many, the Madras High Court have granted a three month extenstion to Dr. Surinder Singh to continue as the Drugs Control General of India (DCGI) for three more months until October 31, 2011.

Earlier, the Government of India had on June 8, 2011 extended the appointment of Dr Surinder Singh as DCGI until 31. 3. 2012. The DCGI’s deputation tenure was to expire on June 21, this year.

A public interest litigation (WP 15607/2011) against the appointment of DCGI and the extension was filed by T K Ramalingasamy, a former regulatory officer of the Tamil Nadu Drugs Control Department. Advocate P T Asha from Sarvbhouman Associates, appeared on behalf of the petitioner. She quoted the reference of a government order (GO) passed by the central government that the period of deputation of a government servant should not exceed beyond five years. She said Dr Singh has already completed five years on deputation.

Additional Solicitor General of India, Mohan Parasaran, who appeared on behalf of the Government assured the court that Government would speed up the process of recruiting a new DCGI.

NPPA update on Overpricing

The outstanding arrears by pharmaceutical companies on the grounds of overcharging continued to increase steadily with Cipla remaining the leader of the pack, even as the recovery attempts by the National Pharmaceutical Pricing Agency (NPPA) did not improve in proportion to the rise in the arrears.

According to the latest list published by the NPPA, the agency sent out demand notices to the companies in 804 cases for a total recovery of Rs.2350.28 crore till May 31. The total recovered amount stood at Rs.210.20 crore, since the inception of the price monitoring agency.

Though all the major pharma companies find their way in the default roaster, Cipla Ltd continued to lead the tally with a total of nearly Rs.1400 crore, which accounted for more than 60 per cent of the total dues owed by the entire pharma industry of the country. Sources said most the cases with Cipla are in the courts still. Big companies figured in the list included Cadila, Ranbaxy, Dr Reddy’s Lab, Pfizer, GlaxoSmithKline and Merck.

During the last four months, the NPPA has sent notices in 18 cases, demanding over Rs.22 crore. The recovery during this period stood merely at Rs.2.14 crore. According to the previous compiled list as on January 31 this year, the total number of cases were 786 and the total arrears were Rs.2328.52 crore. The total amount recovered by the end of January was Rs.207.86 crore.

Till October 31, 2010, the total arrears were Rs.2208 crore, thus arrears grew by Rs.142 crore in the six months whereas the recovery was to the tune of Rs.8 crore during the same period. The NPPA has intensified efforts to recover the outstanding arrears in the recent years. As part of the measures, the NPPA has also started referring overcharging cases to district collectors of concerned States for revenue recovery.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2011

Positive opinions for new medicines adopted

The Committee adopted positive opinions recommending the granting of marketing authorisations for the following new medicines:

Buccolam (midazolam), from ViroPharma SPRL, intended for the treatment of prolonged, acute, convulsive seizures in paediatric patients from the age of 3 months to 18 years. The review for Buccolam began on 22 September 2010 with an active review time of 210 days. This is the first CHMP recommendation for a paediatric-use marketing authorisation (PUMA).Eurartesim (dihydroartemisinin/piperaquine phosphate), from Sigma-tau Industrie Farmaceutiche Riunite S.p.A., intended for the treatment of uncomplicated Plasmodium falciparum malaria. The review for Eurartesim began on 22 July 2009 with an active review time of 210 days. This is the first CHMP recommendation for an anti-malaria medicine.

Trajenta (linagliptin), from Boehringer Ingelheim International GmbH, intended for the treatment of type 2 diabetes mellitus to improve glycaemic control in adults. The review for Trajenta began on 21 July 2010 with an active review time of 210 days.

Votubia (everolimus), an orphan medicine from Novartis Europharm Ltd, intended for the treatment of patients aged 3 years and older with subependymal giant-cell astrocytoma (SEGA) associated with tuberous sclerosis complex. The review of Votubia began on 18 August 2010 with an active time of 210 days.
The CHMP recommended the granting of a conditional marketing authorisation for Votubia, which means that further evidence on the medicinal product is awaited. In the case of Votubia this relates to the submission of the final results from pivotal phase III study and the long-term follow-up on the efficacy and safety in SEGA patients. The European Medicines Agency will review new information within one year and update the product information as necessary.

Negative opinions for new medicines adopted

The Committee adopted negative opinions recommending that marketing authorisations should not be granted for the following orphan medicines:

Bronchitol (mannitol), from Pharmaxis Pharmaceuticals Ltd, intended for the treatment of adult patients with cystic fibrosis.
Luveniq (voclosporin), from Lux Biosciences GmbH, intended for the treatment of chronic non-infectious uveitis.

SALE OF BANNED DRUGS

Last week Pharmabiz reported about a series of raids conducted by the office of DCGI on pharmacy outlets in Delhi and Rajasthan for selling two of the banned drugs namely gatifloxacin and tegaserod. The officials stated to have seized huge stocks of the brands of these companies namely Lupin, Dr Reddy's, Sun Pharma, Cipla, Hetero Drugs, Torrent Pharma, Aristo Pharma, Intas and others. The inspectors of the Central Drug Standard Control Organization have conducted 135 raids in over 90 pharmacies in Delhi and Rajasthan. DCGI had banned gatifloxacin, an antibiotic and tegaserod, a chronic constipation drug for their adverse effects on last March 16. The order required the drug companies to withdraw their brands from the market with immediate effect. The decision to recall these drugs from the markets was on the basis of recommendations of the Drugs Technical Advisory Board. It is indeed surprising that these banned products continued to be sold in retail outlets even after three months of their ban. It is possible that the sales were taking place without the knowledge of the companies as most of the makers of these drugs are large and reputed companies. However, the manufacturers cannot pretend to be ignorant about such illegal sales of their products in the trade channels. Most of them have the monitoring system to track the sales of their products throughout the country.

Now, prior to the ban order of gatifloxacin and tegaserod in last March, DCGI had also banned drugs like nimesulide, cisapride, phenylpropanolamine and human placenta extracts for their adverse effects. These drugs have also been in the market for last many years and belonged again to large companies. The manufacturers, shortly after the ban, moved Madras High Court against the order and got an interim stay of the DCGI order and the case is pending in the court. CIPI, representing small drug units has, however, withdrawn its case against the ban from the Madras HC a few days ago. All these drugs have been already banned in developed nations, like the US, UK, Canada, Sweden, Denmark, Australia, New Zealand and Japan several years ago. What is being noticed in India for some time now is growing resistance from pharmaceutical companies to any withdrawal order from the regulatory authorities even if the drug is highly unsafe. One has to accept the fact that no drug is absolutely safe and all have side effects. Safety only means that the benefits of the drug outweigh the risks. Drug authorities worldwide grant marketing approval for drugs only after consideration of this principle of cost benefit. Continuation of marketing drugs with serious ADRs could be highly dangerous to the millions of patients who are taking them. Therefore, both the industry and trade have to cooperate with the regulatory authorities in withdrawing potentially harmful drugs from the market in public interest. And when the country’s most authoritative body recommends a ban on the basis of safety parameters, no pharmaceutical company has the moral ground to challenge such an action.

Sri Lanka blacklists Indian drug suppliers

Sri Lanka's Ministry of Health has blacklisted at least a dozen of Indian drug suppliers for violating tendering procedures and supplying low quality medicines, officials said.

Health Minister Maithripala Sirisena has directed his officials to look elsewhere for supplies to meet urgent requirements, officials added.

"I have been told by my officials that Indian companies have violated tender procedures or have supplied low quality drugs," Sirisena was quoted as saying in local press. The Indian companies' shortcomings have led to shortages in some urgently needed medicines, officials charge.

Around 100 Indian drugs suppliers are in the Colombo Health ministry's suppliers roll, but the companies in the spotlight have been blacklisted for supplying sub-standard medicine while paying no heed to deadlines for supply and violating procedures.