The Supreme Court's rejection of Swiss drug maker Novartis AG's demand for exclusive patent rights on cancer drug Glivec, has given a boost to the production of cheaper generic versions of lifesaving drugs in the country.
It will help maintain India's role as the world's most important provider of cheap medicines, which is critical in the global fight against HIV/AIDS and other diseases. India, being the pharmacy capital of the world, can continue to produce affordable, high-quality medicines now without the threat of patents for minor modifications of known medicines, say experts.
Stressing the dominance of India as the pharmacy of the world, Union Health Minister Ghulam Nabi Azad recently said in the Lok Sabha that every fifth tablet, capsule and injectable in generic drugs consumed anywhere in the world is manufactured in India.
India's generic drugs industry, which has boomed during the last few decades, has long been a lifeline to poor countries. India has one of the best developed pharmaceutical industry and produces about 20 per cent of the world's drugs. Over 74 manufacturing plants in the country have US FDA approval which is second only to the US where 733 companies are WHO approved. Currently many top Indian companies are exporting generic drugs worth Rs.45,000 crore every year to many countries including the US and Europe.
But ironic as it may sound, drugs are beyond the reach of people, especially the poor because their prices are very high. It is not that the cost of R&D and manufacturing is high, but because the profit margins are exorbitant and in many cases exploitative.
Instead of the patient, it is decided by the doctor as to which brand is to be purchased. Branding creates artificial monopoly and enables drug companies to put very high MRP despite existence of competitors. Drugs laws prohibiting substitution of brands of same generic drug further enable the pharma manufacturers to assign any price whichever suits to them.
Moreover, drug consumers are highly vulnerable and their requirement is urgent, hence they are not in a position to compare prices, bargain or choose. The pharmaceutical companies are operating in a manner which keeps prices of drugs (including the essential drugs) high so that profitability is maximized.
In the pharmaceutical sector, manufacturing the cost of a drug is relatively low, compared to the price it is sold . The actual drug prices are usually 2.20 per cent of the prevalent MRP. If medicines can be made available at lower costs, the cost of treatment for most illnesses could be reduced many times. Thus, there is a need to provide medicines free or at affordable prices, especially for the poor and there is a scope for this because the cost of production of most drugs is very low.
There are many initiatives to make the quality generic medicines available in private sectors for open sale. Some of them include the establishment Jeevandhara stores in Andhra Pradesh , Janatha Bazar generic drug stores in Karnataka and Jan Aushadhi Stores of Department of Pharmaceuticals of Government of India.
“Instructions have been issued from time to time to all Central Government hospitals and CGHS dispensaries to prescribe generic medicines to the maximum extent possible. The State Governments have also similarly been asked to instruct their doctors to prescribe generic medicines” says Ghulam Nabi Azad.
Some of the states like Rajasthan is taking a number of initiatives to take the medicines to the public. The first such initiative was started in Chitodgadh district in Rajasthan by the district collector followed by APMSC in Andhra Pradesh.
Rajasthan
The main purpose of the low cost generic drugs initiative in Rajasthan is to make medicines available, accessible and affordable to the poor and disadvantaged sections of the society.
The price monopoly of drug manufacturers was broken by procuring drug by tender system & by pursuing doctors to prescribe by the generic (salt) name. These medicines were made available at Government hospital’s free drug distribution counters and fair price generic medicine shops.
Patients were made aware that generic medicines are of the same quality i.e. in identity, purity, strength & effectiveness as branded medicines.
The state government has issued various circulars which direct all the government doctors to use generic names, instead of the brand names. Doctors were sensitized about the plight of the poor.
About 400 essential drugs etc are provided free of cost at about 15000 Drug Distribution Centre located in Govt. hospitals, right from medical college hospitals to PHCs and Sub Centers. These medicines are procured by generic name through transparent open tender and pharmaceutical manufacturers supply them to the state govt. at low prices.
Most of the commonly use drugs are given free of cost but other drugs, short supply drugs, surgical, implants etc are provided much below MRP at these life line drug stores. These are operated by the Rogi Kalyan Samiti which invites bids to purchase the drugs generic companies from the local stockiest at competitive prices. After preparing comparative statement and finding out the most economical price the generic medicines are made available for sale. There are 72 such stores in all medical college hospitals, district, sub-district & satellite hospitals in Rajasthan.
The consumers were made aware by pasting list of free medicines outside the free drug distribution centres. Similarly, comparative price lists are displayed outside fair price medicine shops.
Assam,West Bengal
At the same time in order to prevent doctors from flouting government norms for generic prescriptions and from promoting branded drugs instead of implementing government policies, the health ministries of Assam and West Bengal have initiated steps to monitor and scrutinize the prescription pattern at government hospitals .
The state governments in West Bengal and Assam have introduced a policy to distribute cheaper and quality generic drugs to the patients coming to the government hospitals. Before implementing the generic prescription policy, the health departments in these two states convened a meeting of medical officers and physicians to arrive at a consensus for not promoting costlier and branded drugs. Even then, according to sources, some doctors are flouting the governmental norms and prescribing only branded drugs under the pretext that brands are quality oriented. To address these violations and save the poor patients from out of pocket expenses, the two eastern state governments have introduced certain steps including auditing of prescriptions.
While the West Bengal government introduced auditing of prescriptions at the state run hospitals, the government of Assam introduced prescription pads with duplication facility at the hospitals. The Pads are supplied by NRHM and it is designed in such a way that a copy of the prescription written by the doctor should be kept in the hospital for auditing /verification and the original should be issued to the patient. In every month, a random of 10 per cent of the prescription will be checked by a Committee for generic prescription and auditing. Besides, a quarterly check of 20 per cent of all prescriptions will be carried out by the member-secretaries of the district health societies. The member-secretaries are officers in the rank of joint directors in the health services.
The government has also instructed the district medical officers, principals of medical colleges and superintendents of civil hospitals from top to bottom that a list of available and non-available generic medicines should be displayed on the signage boards in front of the pharmacy and of the office complex. The health secretary’s circular says that disciplinary action will be initiated against erring officials for violation of government directives.
For the smooth conduct of auditing of prescriptions, the health department in West Bengal has formed special pharmacovigilance committee comprising pharmacology specialists.
Karnataka
Karnataka government last year has teamed up with State Cooperative Consumer Federation to set up 20 Janatha Bazar generic drug stores across the state to make available affordable drugs to the poor patients in the state. The initiative taken by the state government was aimed to sell generic subsidized drugs at 50 per cent less than the MRP printed on it. Four pharma companies Cipla Torrent, Sun Pharma and Intas had consented to supply generic medicines at subsidized costs to these stores.
According to Health and Family Welfare Minister Aravinda Limbavali the generic medical shops would be handed over to co-operative societies, missionaries and non-governmental organisations on a non-profit basis.
Maharashtra
A day after a landmark order of the Supreme Court on generic drugs, the Maharashtra government on gave its own thumbs up to generic drugs. Besides using generic drugs for all medicine supplies to public hospitals, health minister Suresh Shetty also informed the legislative council that the government would formulate a module to spread mass awareness regarding generic drugs and their benefits.
According to Minister of State for Health Fauzia Khan, the health department has started purchasing generic drugs and all government and civic hospitals are being provided these medicines. Khan said that a proposal to set up four such stores in the state was in progress.
Dadra & Nagar Haveli
In the Union Territory of Dadra & Nagar Haveli all doctors have been instructed to prescribe generic drugs and also all the purchases of drugs by the health department are on the basis of generic drugs only. The National List of Essential Medicines is being adopted by this UT Administration.
The health department has been instructed to conduct a massive campaign for public awareness about generic drugs and acceptance of generic drug of standard quality and removing the tag of not of standard quality.
Orissa
In Orissa - Indian Red Cross Society, Orissa Branch, has been given the charge of opening generic medicine stores in the state. Doctors in public health institutions have been instructed to prescribe generic drugs. Orissa has adopted a list of essential drugs in generic name. The essential drugs list is updated every two to three years as per the WHO model list and rational list of essential medicine.
Drugs are being procured through open tender system i.e. National competitive bidding, local small scale industries and DGS&D (CPSU) rate contract holders as per IPR resolution and Government of India guidelines from time to time.
Generic drugs are being procured by Government and distributed through Govt stores. Steps are being taken for public awareness campaign for use of generic drugs.
Andhra
In Andhra the chain of Jeevandhara Sanjeevani Pharmacy generic drug stores launched with the support of the state government have turned out to be a big hit among the poor patients and have been doing good business. Started with sales of just Rs.2000 per day in 2010, today the outlets are having a sale of Rs.25,000 to Rs.28,000 every day. All the 330 categories generic drugs are offered at about 40-90 per cent discounted rates on the MRP to the patients.
In just a span of one year, from 2010 to 2011, even while the generic drug stores were in pilot stage, the outlets have recorded a total sale of Rs.1.3 crore, which would otherwise have cost Rs.3 crore to the patients if the same were purchased from the private pharmacies.
At present only two generic pharmacy stores are fully operational in the state, one each at Osmania General Hospital and Gandhi Medical Hospitals in Hyderabad. Two more generic drug stores are operating on a pilot basis in Nellore and Srikakulam districts in the state.
Very soon the Red Cross Society of India is planning to open another outlet at Nilopher children’s hospital in the city. In the second phase, the government in coordination with the Red Cross Society is planning to open more generic outlet in all government hospitals in each district.
Kerala
Following the footsteps of Andhra Pradesh Medical Services Corporation (APMSC), which started Jeevandhara Pharmacies for selling generic drugs on discounted rates, the Kerala State Medical Services Corporation Ltd (KSMSCL) commenced its much publicized ‘Karunya Community Pharmacy’ to provide 20 to 60 per cent discounts on the cost of all branded prescription drugs for the benefit of the common public ailing from various diseases last year.
Kerala is the third state in India to start retail pharmacies in government sector for the sale of drugs at lower rates. The third phase of the Karunya Community Pharmacy project of Kerala Medical Services Corporation (KMSC) was launched recently simultaneously at the medical colleges at Thrissur and Alappuzha last week. All kinds of specialty drugs will be available in these units.
After the two units started last year in Thiruvananthapuram district, the second phase of the project was launched on February 6 this year at the medical college campus at Kozhikode where the third unit of the Karunya pharmacy was opened. According to sources, the Karunya pharmacies are selling specialty drugs at a rate of 20-93 per cent discounts.
Tamil Nadu
The Tamil Nadu Medical Systems Corporation has developed an excellent model of centralised procurement and decentralised distribution of quality-assured generics through public healthcare facilities.
Tamil Nadu's drugs procurement and distribution mechanism is driven by a competitive tendering process and an enabled supply chain management system. The competitive tenders at the centralised procurement stage ensure that the lowest bidder wins. This sets the stage for a robust weeding-out phase wherein a branded formulation will not stand a chance in the tendering process if it is charging exorbitant prices. In this process, it is the patients who are the winners since they gain access to good quality drugs at the most competitive price.
More Jan Aushadhi stores in the offing
In the meanwhile according to a report from our New Delhi Bureau, though still running behind the schedule the Department of Pharmaceuticals (DoP) is aiming to have 3150 Jan Aushadhi stores by the end of the current Five Year Plan in a bid to promote the generic drugs.
Only 147 stores could be opened so far although the revised plan was to have at least 612 generic outlets by March this year. The campaign failed to pick up momentum largely because of the lacklustre attitude by different state governments, the report said.
As part of the campaign, it is intended to open at least one Jan Aushadhi Store in every district of the country to begin with, followed by at least five stores in each district so as to have 3150 stores by the end of the 12th plan. The DoP is now also focusing remote areas like North Eastern States, Andaman & Nicobar Islands.