Wanted Franchise or PCD Distributors for pharma company from Gujarat

Wanted Franchise Distributors for pharma company from Gujarat

Following are the districts vacant for franchise from Gujarat

Ahmedabad

Amreli

Anand

Barauch

Bhavnagar

Dahod

Gandhinagar

Jamnagar

Mehsana

Narmada

Navsari

Panch Mahal

Patan

Rajkot

Sabar Kantha

Surat

Surendranagar

The Dangs

Vadodara

Valsad

Junagadh

Kheda

kachchh

Wanted Franchise or PCD Distributors for pharma company from Kerala

Wanted Franchise Distributors for pharma company from Kerala

Following are the district vacant for franchise from Kerala

Alappuzha

Ernakulam

Idukki

Kannur

Kasaragod

Kozhikode

Palakkad

Pathanamthitta

Thrissur

Thiruvananthapuram

Wayanad

Wanted Franchise or PCD Distributors for pharma company from Karnataka

Wanted Franchise Distributors for pharma company from Karnataka

Following are the districts vacant for Franchise in Karnataka

Bangalore Urban

Bangalore Rural

Belgaum

Bellary

Bidar

Chamarajanagar

Chikballapur

Chikmagalur

Dakshina Kannada

Davanagere

Dharwad

Gadag

Gulbarga

Hassan

Haveri

Kodagu

Koppal

Mandya

Mysore

Raichur

Ramanagara

Shimoga

Tumkur

Udupi

Uttara Kannada

Yadgir

Wanted Franchise or PCD Distributors for pharma company from Maharashtra

Wanted Franchise Distributors for pharma company from Maharashtra

Districts in Maharashtra vacant for franchise

Yavatmal

Jalgaon

Chandrapur

Akola

Jalna

Dhule

Amravati

Kolhapur

Wardha

Aurangabad

Latur

Washim

Beed

Nandurbar

Bhandara

Nashik

Buldhana

Osmanabad

Gadchiroli

Gondia

The need to bring some control in the misuse of brands in pharmaceutical industry

Multiplicity of brands in pharmaceutical industry has been a matter of concern for the regulatory authorities in the country for some time as they often lead to confusion and prescription errors amongst the medical practitioners. Although the practice of using same brand name for a particular pharmaceutical product by different companies is rather rare, pharma companies do use variants of an established brand name to confuse the practitioners and patients. Usually medium and small drug units are found to indulge in this unethical practice in small towns to take advantage of the goodwill created by an established brand over a period of time. Misbranding is another unethical practice amongst the pharma companies. 

It is a dubious way of exploiting an established brand name for a totally different product. Two cases of misbranding that occurred some years ago were that of Disprin Plus of Reckitt Benckiser and Aspro Plus of Nicholas Piramal. Disprin and Aspro were two old and well established aspirin brands in Indian pharmaceutical market belonging to these companies. 

They discontinued these products but launched Disprin Plus and Aspro Plus with paracetamol as the main ingredient to take advantage of the brand equity of Dispirin and Aspro. Such cases of misbranding can endanger lives of patients as most of them may not check the change of the ingredient in a product.

The need to bring some control in the misuse of brands in pharmaceutical industry has been long felt by the authorities but no effective action was ever taken by the health ministry or the chemicals ministry so far. The Supreme Court had issued an order around 10 years ago directing the government to develop a proper registration system for drug brands in coordination with drug regulatory authorities and the trademark office to prevent the confusion. But, nothing has been done by the concerned ministries after the order. 

Now last week, a leading financial daily reported that the government had held preliminary discussions over the issue with a few industry stakeholders. What is to be first realized is that the Indian pharmaceutical market has nearly one lakh brands although drugs approved for marketing are around 600. This is too large a number. The number of brands must be multiplying every day as the product licenses are being issued drug control authorities in 28 states with no coordination. 

The Central government has no idea about what is the actual number of brands floating in the market and their compositions. Ideally a proper audit of pharmaceutical products circulating in the market should be undertaken first and then take steps to weed out undesirable brands from the market. This may not be an easy task but needs to be done. Establishing a centralized database of brands and streamlining the issue of brands can then be done with proper coordination and support of state drug authorities.

In Mumbai has made cutting of tablet strips mandatory.

A recent circular issued by the Food and Drug Administration, Maharashtra to retail chemists in Mumbai has made cutting of tablet strips mandatory. The circular directed the chemists that strips should be cut if the customer so desires. In fact, most of the chemists in the country are indulging in this practice for several years now. 

Therefore, the rationale to issue such a circular is not very clear. What is actually required is to curb this practice in the interest of the consumers. It is possible that some poor patients may ask for strip cutting if the prescribed drug is an expensive one. But that is to be discouraged by the pharmacists at the counter in the interest of the patient safety as it could lead to under dosing and consequent in effectiveness of the drug. Incorrect and inadequate dosage of medicine by the patients is one of the main reasons for the recurrence of diseases among the poor. As such the strip cutting is not a desirable practice as that can lead to sale of expired drugs to unsuspecting and illiterate customers. At a time when some of the drug companies are colluding with retail chemists to sell expired drugs, strip cutting can actually help such unethical practices to flourish. It is obvious that when the strips are cut, the ingredient details, expiry date and batch numbers may not be there on the cut portion of the strip. This could be dangerous to patients.

Although Maharashtra FDA directed the chemists in the state in this regard, there is a lot of confusion on the issue amongst the pharmacist community including amongst regulatory officials. Indian Pharmaceutical Association, the national body of pharmacists in the country has alreadytaken objection to idea of legalising strip cutting. It has informed the DCGI that there is no

clear-cut provisions in the law whether strip cutting is allowed or not and regulatory officials have different views on the matter. 

IPA has rightfully urged the DCGI that the issue should be included in the agenda of the next meeting of the Drug Technical Advisory Body for discussion and appropriate action. Earlier pharmaceutical companies used to sell almost all drugs belonging to different therapeutic categories in strips of 10. Marketing of tablets in multiple strip sizes and different strength developed over the years as the drug companies wanted to escape price control. Today, many pharmaceutical companies including reputed ones have strip sizes of 6 to 10 and 15 to 30. 

In some cases, there are even strips of 30, 40 and 50. Such huge sizes of strips can certainly create a chaotic situation and some discipline needs to be brought in. A rationalization of strip sizes is necessary based on the therapeutic value of the drug, dosing and cost of medicine.

Public health problems today is the growing antibiotic resistance

One of the world's most pressing public health problems today is the growing antibiotic resistance due to its irrational use over the years. Confirming a bacterial infection, selecting the appropriate antibiotic for the infection and educating patients about the importance of taking therapy as prescribed by physicians are considered critical in treating infectious diseases. 

Bacteria can become resistant in several ways and all of which involve changes in their genetic material or genes. These altered genes enable the bacteria to either destroy the antibiotic or block its ability to inhibit bacterial growth. The laws of natural selection suggest that all bacteria will eventually become resistant to antibiotics at some point. Repeated and improper use of antibiotics are two main causes for increase in resistant bacteria world over. It is estimated that up to 50 per cent of antibiotic prescriptions given in the community settings are not actually needed. 

Patients too contribute to antibiotic resistance by requesting physicians to prescribe antibiotics even if they do not have a bacterial infection. Noncompliance of patients to the antibiotic treatment regimen is another contributory factor for resistance which has become a significant patient safety concern today. In India, scientific debate on antibiotic resistance has taken a serious turn in the wake of a recent controversy over a reference made in the medical journal, Lancet, regarding the superbug called New Delhi metallo-beta-lactamase 1 (NDM-1). 

The superbug is stated to be resistant to the most powerful antibiotics and the circulation of the Lancet report did hit the image of India as a destination for medical tourism and cheaper treatment facilities. Scientific community in the country did take objection to the reference of New Delhi in the name, NDM-1, as it can give a wrong impression that it originated from India. What is, however, more important now is how to bring a control on the antibiotic resistance in the country. 

And it is creditable that the Union health ministry swung into action and set up a task force to review the current situation regarding manufacture, use and misuse of antibiotics in the country and also to initiate studies documenting prescription patterns and establish a monitoring system for the same. The report has been already placed before the Drug Consultative Committee a few weeks ago. Now, DCGI decided to introduce a set of new rules to regulate the sale of antibiotics and add a separate schedule under the Schedule H of the Drugs & Cosmetics Act. 

The new Schedule, HX, is expected to be added to the D&C Act to make it compulsory for patients to carry duplicate prescriptions for buying antibiotics from the chemist shops. One copy of the prescription has to be kept by the chemists for audit up to one year. These are all highly desirable initiatives from the health ministry and not many developing countries have taken such steps to counter this new threat. What is to be seen now is how effectively and fast the health ministry and drug control machinery of the country will be enforcing these critical regulations.

Code of ethics for doctors

The Department of Pharmaceuticals seems to have abandoned its initiative to evolve a mechanism for discouraging the drug companies from bribing doctors for prescriptions. After convening some meetings last year in the wake of growing public outcry against this unethical marketing practice of pharma companies, the officials in the Department has now become virtually inactive. The DoP had last year asked the industry to evolve a common code of ethics for all pharmaceutical units as existing codes do not cover members of all the pharma industry associations. 

The OPPI was asked to take lead in this matter and compile a marketing code in consultation with all major industry associations. There were sharp differences amongst the industry associations over the proposed common marketing code. While the industry associations representing big and medium pharma companies wanted a uniform code of marketing practices but not binding on the industry, the associations representing 5000 small companies were in favour of a uniform code which should be legally binding on the companies. The stand of smaller pharma companies was based on the belief that only a legal document can ensure compliance of the code and any violation can invite punishments both in terms of money and jail term.

Subsequently, Medical Council of India, the regulatory body for the conduct of the medical profession, has been making some efforts to curb the practice amongst the doctors. It had come out with a code of ethics for doctors prohibiting them from receiving gifts, travel facilities, hospitality, monetary grants, endorsements, etc. As per this code, medical practitioners are prohibited from receiving favours from pharma or healthcare companies under any pretext. 

MCI has the powers to regulate the practice of medical professionals and take action against them. But, MCI has not been able to bring any discipline amongst the medical practitioners as yet. Now, the question is how effectively the MCI will be able to monitor the conduct of lakhs of doctors spread across the country. The practice of bribing doctors by pharmaceutical companies for generating prescriptions has been part of their marketing strategy for many years but has not been causing any serious concern. It has now grown to a major public health issue with the increased competition amongst the pharma companies to capture the market share.

 It is believed that a major part of the cost of prescription drugs is due to loading of promotional expenditure on their prices. Today, more than 80 per cent of the drugs marketed in the country are outside the purview of the DPCO as several new drugs have been allowed to be marketed in the country after the DPCO,1995. Considering this, DoP should not have given up its initiative to check this unethical practice just because there is non cooperation from some industry bodies. Such a stand from a section of the industry should be expected. Even now, DoP should take up the matter and make a serious attempt to implement the marketing code with the support of MCI.

Ban three unsafe drugs namely nimesulide, cisapride and phenylpropanolamine

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.

Violations of Drug Price Control Order

A proposal to set up price monitoring cells in state drug control administrations for tracking violations of Drug Price Control Order was made by the ministry of chemicals some months ago. The proposal was made in the context of increasing number of price violations and circumvention of DPCO by a large number of pharmaceutical companies over the years.

As per the latest data compiled by ORG-IMS, the number of prima facie violations were rising steadily in the recent years. From 2007 to November 2010, 2782 samples of non-scheduled drugs were collected and prima facie violations were detected in as many as 1495 cases. Out of these, 956 samples were referred for overcharging. Similarly, out of the 309 samples collected from the market during June 2009 to March 31, 2010, in 153 cases the companies were found to have violated the norms and 139 were referred for overcharging. However, only 14 samples finally came under price fixation. During the current year up to November 2010, 348 samples were collected from the market and 125 were found to be with prima facie violations. It is extremely difficult for NPPA to detect such growing number of violations all over the country considering its current staff. NPPA put up the proposal to set up price monitoring cells in the state was in this context. It is unfortunate that the Planning Commission is yet to act on the proposal.

The chemicals ministry has been regulating prices of 74 drugs since 1995 through NPPA and later it also started monitoring prices of several non scheduled drugs as many of them remained outside the price control in the absence of finalization of a new drug policy. Formulations of over 500 drugs are being marketed in the country by 5000 companies. Now, as the Planning Commission is taking its own time to consider the NPPA’s proposal, the regulatory body feels that building its own team of officers to pick up random samples from the market would be a better option. It has, therefore, urged the Pharma Department to process the files for creating its own cells in the States.

In fact, this is one of the key suggestions made by the chemicals ministry to be incorporated in the long pending national pharmaceutical policy. Currently NPPA has very limited staff available to it but still it monitors the prices of non scheduled formulations through various methods like scrutiny of price lists submitted by manufacturers, analysis of monthly Stockists Secondary Audit Reports published by IMS-Health and complaints and references received from official and non- official sources. Considering the massive number of formulations in the domestic market and with only a small number of them coming under price fixing by way of scheduled drugs, the quantum of samples needs to be increased for better price monitoring and strengthening of NPPA with own monitoring cells would be a better option.

DCGI had then ordered an investigation to assess the safety profile of the drug in the Indian

It is after several years of debate, the Drug Controller General of India decided to ban the manufacture and sale of 4 controversial drugs namely nimesulide suspension, cisapride, PPA and human placenta extracts in the country in February last. The notification to this effect was issued on February 10 after Drug Technical Advisory Board recommended their withdrawal from the market. The DTAB has been examining the safety profiles of the drugs for some years and advised their recall from the market as their adverse effects outweigh the benefits. 

These drugs have been already banned by many developed countries over ten years ago. In India, the dangerous side effects of nimesulide was brought to the notice of the DCGI first time by the Ahmedabad based Consumer Education and Research Centre in April 2000. DCGI had then ordered an investigation to assess the safety profile of the drug in the Indian context and nothing further happened and the drug remained in the market since then. Obviously there has been pressure on the office of DCGI to not to issue the ban order as some of the drug companies stand to lose several crores of rupees of business. However due to persistent pressure from independent medical experts and consumer groups, DCGI came out with the notification.

The decision for withdrawal of four drugs by the DCGI was well received by the pharma industry associations and there has been no serious objections to the order as it is in larger public interest. Subsequently, the state drug controllers have started taking the follow up actions to enforce the order. 

In fact, Andhra Pradesh and Gujarat drug control departments have already issued stop sale orders of these four drugs in their states within a few days of the DCGI’s directive. The only demand from some of the associations representing small scale units was to postpone the ban of sale these products till the expiry of stocks in the trade channels. That is a reasonable request and state drug controllers have already agreed to consider this demand. What is disturbing the DCGI and medical experts now is the stay granted by the Madras High Court against the government ban order last week on a petition filed by a leading pharmaceutical company. 

The Court should have duly considered the entire background behind such a government order before stalling it. Any continuation of marketing drugs with major ADRs could be highly dangerous to the millions of patients who are taking them. And when the country’s most authoritative body recommends a ban on the basis of technical findings, no pharmaceutical company has the moral authority to move court against such a step. Now having issued the order and state governments started acting on it, the DCGI has to uphold the order in the public interest. DCGI’s decision to move the Supreme Court for vacating the stay is thus just humanitarian and fully justified.

Some 700 million Indians in the villages and non-urban areas don’t have access to healthcare

With multiple issues blocking access to healthcare in India, more than a million people die every year due to lack of healthcare access, most of them being women and children, according to a white paper by Pricewaterhouse Coopers and India Health Progress.

“Some 700 million Indians in the villages and non-urban areas don’t have access to healthcare facilities because around 80 per cent of the specialists and medical facilities are located in urban areas. Around 350 million Indians live Below the Poverty Line (BPL) and survive on less than Rs.100/- per day, putting nearly all medicines out of their reach. Even when the medicines are available free, the poor lack the meagre resources to travel to the nearest government-supported Primary Health Centre (PHC) located kilometers away from their village. Finally, these PHCs are often under-equipped and under-staffed,” said the white paper, mainly prepared on 'health insurance.'

Health insurance has historically played a pivotal role in improving access to healthcare around the world. Unfortunately, less than 15 per cent of the Indian population is covered under some form of health insurance, including government-supported schemes. Only around 2.2 per cent of the population is covered under private health insurance, of which rural health insurance penetration is less than 10 per cent, said the paper which has recommended insurance as a key pillar to increase access to healthcare.

“India’s diverse population has limited purchasing power. Penetrating this market therefore requires innovative insurance products at multiple price points. But innovation in the current Indian health insurance market needs to evolve considerably, with health insurers stacking their portfolios with multi-level, differentiated long-term products. Public and private sector players have already shown the way by introducing innovative insurance products with premiums as low as Re. 1 per day and Rs.10 per month, catering to community as well as individual insurance needs. Such low-priced products can play a big role in ensuring higher healthcare access and better health for all sections of Indian society,” it said.