Generic Drugs

Feb 20 • Opinion • 1375 Views • No Comments on Generic Drugs

GENERIC DRUGS

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The Government is pushing generic drugs in a big way to replace expensive branded medicines and bring down the prices of essential drugs. The move is also expected to prevent promotion of branded drugs and break the doctor-pharmaceutical company nexus that has often been held responsible for exploiting patients. The health department will soon start preparing a list of these generic drugs. The medical community is cautious in its appreciation of the move – it’s “laudable”, they say, but sustaining this over the long term will be “challenging”.

The government has initiated the process of introducing generic medicines in state-run hospitals by opening fair price shops through public-private partnership (PPP). These outlets are selling generic drugs at a whopping rebate on the maximum retail price (MRP), earning kudos from the people, but annoying a major section of drug sellers.

The aim is to start with government hospitals and doctors. They will be barred from mentioning brand names unless it is deemed necessary for any particular reason. The prescription will have to mention the reason. Gradually, all doctors will come under the rule and the era of branded drugs shall come to an end. Sections of doctors are skeptical about the switch-over and believe that it must be preceded by a comprehensive plan. Just one drug store at government hospitals won’t be able to cater to even half the patients. And outdoor patients who might prefer to buy the medicines outside the hospital won’t get them if they are prescribed under generic names. There is also a chance that spurious stuff could be pushed into the market under generic names. Government should take up policies to maintain effective quality control. Also, when a doctor prescribes a branded medicine the onus is on him, but when he prescribes drugs with generic names, the onus of providing the right medicines shifts to the pharmacist, who is often a mere shopkeeper.

Thus it compromises people’s heath. If these limited drawbacks can be removed, Generic drugs have wide scope and a brilliant future prospect especially in the third world countries.

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SCOPE OF GENERIC DRUGS , In today’s world, the scope of generic drugs is increasing everyday especially in diseases such as diabetes, cardiovascular and in microbial diseases etc. Recent expiry of patent has lead to addition of its generic forms to the market. Generic drug is a substitute or a copy of branded drug that satisfies the pharmaceutical standards. Generic drugs are similar in terms of safety, dosage, strength, quality and performance. The only difference lies in its distribution without any patent protection. FDA says that generic drugs are identical or bio-equivalent to the brand name counterpart with respect to pharmaceutical properties.

The generic drugs are cost effective counterparts of branded drugs who have lost there patents. Production of generic products do not require any investment in terms of research. Thus are available at a cheaper, affordable rate. The producer just needs to ensure that the therapeutic activity of a generic product is similar to that of innovators brand, for that they must be pharmaceutically equivalent as well as bio-equivalent .

Generic medicine shall play a vital role in improving the health care system  owing to its quality yet cost-effective treatment especially in terms of chronic/common diseases like diabetes, cancer,etc.  The pathway market capture of generic medicine is laid, its upon the generic companies and government to come up with quality cheaper medicine and policies to spread the cause.

Social Aspect

In the third world countries (focusing on India here), large section of society are below poverty line. These people fail to earn themselves food half the time. Purchasing branded medicine is not an option for this class of people. Half of the time, failing to pay for such expensive medicines proves fatal. therefore, generic medicine is the much needed alternative that government can come up with.

Owing to the fact that generic drugs are the exact replica of branded drugs,it is very obvious for this backward section of the society to get a cure.The increasing competition between domestic multinational companies is helping to market cheaper drugs. Most of the Indian pharmaceutical companies are primarily generic based; they spend time and money on generic research. Generic market has now also increased due to expiry and shortcoming of patents.

Medical Council of India Code on Generic Drugs:- Recently, Medical Council of India Code of Medical Ethics 1.5 issued a re-notification and said that the rule 1.5 should be followed in its spirit. The rule says: Medical Council of India Code of Medical ethics: 1.5 Use of Generic names of drugs: Every physician should, as far as possible, prescribe drugs with generic names and he / she shall ensure that there is a rational prescription and use of drugs.

  1. The phrase “Prescribe drugs WITH GENERIC NAME”: It is not the same as prescribing GENERIC DRUGS; it only means that the name of the chemical salt should also be written.
  2. Whether you write a brand with a salt name or you write a salt name with name of the pharmaceutical company, it is the same.  In one the company derived name of the salt becomes a salt and in the other, the salt linked to a company becomes a brand.
  3. Mechanisms have to be evolved so that a quality, safe and affordable drug can be given to the patient.
  4. One of the answers is price control on MRPs by the government.
  5. The IMA members should maintain the rational use of drugs while choosing a drug and ensure it qualifies the criteria: quality safe drug and yet affordable”.
  6. The so-called nexus between doctor and chemist or a pharma company, where a doctor is writing a particular brand, a costly brand or a brand only available with particular chemists should be considered unethical.
  7. All doctors should write a salt name along with the name of the company or the brand name which is of quality and safety and yet cost effective.
  8. Since in our country, patients have very limited access about the information of drugs and even persons employed in chemist shops are also not qualified, proper checks and balances are essential to  ensure that patients get the best medicine on physician prescription. Doctors along with Govt. machinery and price control are the only mechanisms to ensure patient getting proper medicine.
  9. IMA firmly believes that the Govt. should control the MRP of drugs, generic or branded so that benefit reaches the common man.
  10. The web site of Drug Controller should mention the name and addresses of manufacturing and marketing companies authorized by them to ensure the trace-ability of the product. It should also mention the MRP of drugs.

If all the above directions are followed in true spirits by the doctors , branded medicine will cease its existence and the aim to supply cheaper medicine will be fulfilled. Help of doctors and literate people shall foster the goal and lead to establishment of more generic drug shops in the area. The process is slow but steady to bring a huge change and create a healthy society.

Complete abolition of branded medicine is not possible because everyday newer research are being carried out and being made patent. New patents shall take a long time before its generic version could be developed. On the other hand, medicines whose patents have expired should be produced, marketed and advertised properly so that all the section of society gets awareness about it. More number of generic drug shops should be opened in various areas in and around the city with educated chemist for proper distribution of generic drugs.

My advice, it can be smart to try generic medicines. There is no evidence that these products are of lower quality, or less effective than name brand products—though they are not required to go through clinical efficacy trials. Generic drugs are copy of the branded versions and perform well in most of the cases.

In a recent judgement , Supreme Court of India has said that little changes in drugs and saying it to be new invention will not work in developing countries like that of India moreover these drugs are life saving drugs and should not be traded for high profit.

What is your experience with generic medications versus name brand products?

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