Prologue
PM had also announced that the government is working to bring in a legal framework under which doctors will have to prescribe low cost generic medicines to patients hence this article.
Why prefer generics over branded?
Medical Council of India (MCI) had also framed a prescription guideline years back which clearly spells out prescribing generic medicines as per the code of medical ethics stipulated as in the 2002 ethics of MCI Act. Also, a comparative study shows generic drugs have the lowest price as compared to different branded drugs of similar nature, molecule and combination. Maharashtra has ‘Nirmalaya’ a ready reckoner which is handy for prescribing Schedule H, Schedule H1 and Schedule X drugs.
Format given to doctors for prescription of generic drugs
Based on medical code of ethics, Maharashtra Medical Council (MMC) had also issued a standard prescription format for allopathic doctors in the state to boost an accurate, uniform, standard and clear prescription for the sake of patient safety. The new format, prepared by MCI, is applicable for all doctors practicing allopathic medicines across the country. Similarly other state medical councils have their tailor made formats available.
Directives for Maharashtra doctors for generic drugs
In Maharashtra over 80,000 MMC registered doctors are expected to start using the new format across Maharashtra. As per the Maharashtra new guidelines, allopathic doctors must write prescriptions legibly and in capital letters as well as furnish a complete and detailed prescription. The physicians have to also mandatorily mention the patient’s address and keep blank space in which the pharmacist can specify his/her address. The comprehensive format includes the doctor’s full name, his/her qualification, patient’s details, name of the generic medicine or its equivalent along with the dosage, strength, dosage form and instruction, name and address of medical store with pharmacist’s name and date of dispensing, as well as the doctor’s signature and stamp.
Distribution channel for generic drugs
Promoting Nirmalya is a step in the right direction as the Department of Pharmaceuticals (DoP) is also planning to make generic drugs available under the Jan Aushadhi Scheme through retail drug stores across the country. These drugs would range from antibiotics, anti-cardiac, anti-diabetic, anti-infective and gastro-intestinal drugs in six therapeutic segments. As part of the initiative, the government is also planning to involve private players to revive the fledgling Jan Aushadhi scheme which is completely dependent on a handful of public sector units (PSUs) for drug supply that makes it vulnerable to frequent out of stock of generics.
How long it takes for branded drug to become generic
Every new pharmaceutical molecule is patented and copyrighted for international intellectual properly right. This remains valid for 10 years period. “Generic medicines are manufactured following the same quality standards just like other medicines. A company can only develop a generic medicine for marketing once the period of royalty being paid for branding copyrights/patenting of medicine has expired. This is usually 10 years from the date of first authorization of branded drugs.
Punjab Government doctors get set to prescribe generic drugs
All senior medical officers (SMOs), medical officers working in Government Multi Specialty Hospital (GMSH), Sector 16, are directed to prescribe medicines with generic name or medicines available from the hospital pharmacy in GMSH; Civil Hospital Sector 22; Civil Hospital Sector 45; and Civil Hospital Manimajra. The same can be purchased from Jan Aushadi store at GMSH-16.” The SMOs working in the department of gynecology would ensure that no patient is made to spend out of her pocket during delivery in any of above-mentioned health institutions. The updated list of the medicines available in the hospital pharmacy, Jan Aushadi stores is available in the medical institutions every month.
Opposition to idea of generic drugs
The Indian Medical Association (IMA), Chandigarh, had also opposed the idea of making such prescriptions mandatory and instead wanted a regulation on quality and pricing of medicines. Though the IMA has not condemned prescription of generic drugs, the doctors expressed concern regarding substandard and spurious drugs.
Doctors association and IMA wants Government to regulate strictly quality control of generics drugs manufacturing before framing rules for prescription by registered doctors.
With Medical Council of India’s (MCI) direction to all doctors to prescribe only generic drugs in a clear and legible handwriting, the various doctors association of different states are still finding it tough to comply with the directive and expressing their inability to do it, because they have least confidence in the efficacy and quality of generics. Though the government’s intention in asking the doctors’ fraternity to prescribe only generic medicines is to help the patient’s get affordable healthcare, there is no proper regulatory system to continuously monitor the quality, quantity and efficacy of the generic drugs. This may backfire and may cause irreversible damage to the patient’s health creating confusion if they don’t recover from the disease regarding the diagnosis need by doctors. Without proper rules and regulatory quality, quantity and distribution systems with respect to generic medicines, it is impractical to prescribe only generic medicines since they may not be effective creating confusion in diagnosis.
There should be strict regulation on distribution channels like superstockists, stockists and medical stores, where majority of medical stores have appointed non qualified persons instead of pharmacists to dispense medicines, who do not understand the names of generic drugs.
If doctors start prescribing the generic drugs, then no one can control the medical stores who may instead of dispensing the generic drugs may sell the branded medicines of same drug and if this happens, neither the patient nor the doctor who is treating will be satisfied nor the issue of affordable health care will be met. Because, on one hand the patient may not get affordable medicine, while on the other if there is any side effects and adverse reactions then the doctors will be blamed and not pharmacists and medical stores. Therefore doctors against generic drugs are demanding the government to frame rules and regulations with a level playing platform where it should take steps to regularly monitor and test the quality and efficacy of generic medicines in the market and regulate medical stores by asking them not to substitute or replace drugs molecules prescribed by the treating doctors. Secondly the government should fix the prices of generics and branded drugs for certain commonly used medicines by controlling the price and making them uniform both for generic and branded.
The government’s move directing the doctors to prescribe generic medicines is as per World Health Organization (WHO) recommendation because more than 80 percent of suffering population are below poverty line and spending half of their earning on medicines and healthcare. The government directed to doctors to prescribe generic medicines is as such a welcome move and it will drastically cut the healthcare costs and save money of ailing and poor patients.
Reality check of prices for branded and generics
At present, the price difference of generics and branded drugs is 80 percent less for generic as compared to branded. For instance the generic paracetamol drug used for treating fever and headache which costs Rs.6 a strip of 10 tablets, the same medicine with good brand name costs around Rs.30. Like this there are hundreds of medicines generic and branded medicines which differ hugely in their costs.
Conclusion
Overall experts both physicians and pharmacists feel that the government must frame rules and regulations and ensure the quality and efficacy of the generic medicine and should fix the prices of the medicines on a level platform both for generic and branded medicines before implementing compulsory prescriptions of generic medicines by doctors. Second option could be to abolish all brand names after expiry of ten years from the time the molecule is first patented and copyrighted. The government has to fix the basic drug manufacturing activity, the activity of manufacturing capsules, tablets, syrups, injections needs to be monitored for its quality along with compliance by all distribution channels like stockists, superstockists, medical stores shall supply and honour the prescription related to generic drugs prescribed by qualified doctors to cut the health care expenditure for poor, needy patients and bring down the healthcare costs without compromising and the quality of the healthcare, doled to patients in general. Then only it will in real sense meet the directive given by our prime minister, MCI and state medical councils to fulfill the dream of prescription of generic drugs.
