Generic drugs vs patented drugs vs branded drugs vs generic names of drugs

Health Care Comments Off

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.

Interpretation

  1. Use of Generic names of drugs: it’s not use of generic drugs
  2. Every physician should: the word SHOULD makes it binding
  3. As far as possible means to the best of his or her capacity
  4. Prescribe drugs with generic names:  is not the same as prescribing generic drugs. It only means the name of the salt should also be written.
  5. Shall ensure that there is a rational prescription: Rational means prescription of drugs which are evidence based and or with informed consent.
  6. Rational use of drugs: means the same when dispensing.

Thus Medical Council of India says “prescribe drugs with their generic names” which makes sense as what they insist on is that as far as possible we should write the name of the salt also. By writing the name of the salt one will be able to avoid lot of prescription errors and will be able to do and prescribe drugs rationally. For example instead of writing Stamlo 5 mg once daily at night one should write AMLODIPINE (STAMLO) 5mg at bed time.

What is the difference between a patented and a generic drug?

  1. PATENT DRUG means a drug belonging to the original company who has researched the pharmaceutical molecule. The company holds the rights of that molecule for 10 years. During these 10 years, no other company can manufacture and sell this compound. After 10 years, when the patent ends, then any company can copy or modify the molecule and come out with its own brands.
  2. After the patent ends, the patent drug becomes a GENERIC DRUG.
  3. Brand means any drug which is marketed by a company specific name. Both patented and generic drugs can have a brand name. Brand names are so designed that a person can easily remember the drug, or its action
  4. The word GENERIC NAME means the name of the original salt in the compound. It is not the same as generic drug.
  5. A drug can be sold under any of the three categories: Under the name of the generic salt (no brand name), unpopular brand name and a popular brand name. The same company usually sells them under all three categories. Under the salt name they sell in a supply of 100 or more; under unpopular brand name they pitch for an institutional bulk supply and under popular brand name they market for individual doctor’s prescription. The cost of the generic salt will obviously be cheaper.
  6. Actually almost all the drugs produced in India are GENERIC DRUGS (generic equivalents) under different BRAND NAMES. Their prices may vary and are not controlled by the doctors. MRP is decided and permitted by the government.
  7. In USA, BRAND is the name given to the patented drug. After 10 years, the same drug is sold as generic equivalent.

How to reduce the cost of the drugs being prescribed?

  1. One can write AMLODIPINE (Dr Reddy’s lab) instead of a known brand. In that case the chemist should give the unbranded version of the drug, which will be cheaper.
  2. The government should ensure availability of unbranded drugs with generic name.
  3. The reimbursement policy should be to reimburse the cheapest drug (branded or unbranded with generic name version). If a person wants a costlier brand he or she should be allowed to pay the difference.
  4. For example, there are three types of stents in India - the Drug Controller of India approved stents, the European approved stents and American approved stents with Indian stents being the cheapest and the American the costliest. If the Government reimburses all three of them, most of the patients and doctors will opt for the costlier American stents. The Government should reimburse only for the cheapest stents and anybody who wants an American stents should pay the difference.
  5. Similarly, the insurance companies, public sector undertakings, CGHS and related agencies should reimburse for the cheapest drugs and devices. But will be policy makers and the politicians allow that because they are the ones who will opt for costly branded drugs or devices.
  6. Quite often it is argued that the drugs differ in efficacy and bioavailability. That is the difficult to understand as if a drug is approved by the Drug Controller of India, its efficacy should not be a matter of concern or challenge.
  7. There are also arguments that drug licenses are a State subject and the reliability of a state licensed drug may be under question mark.

Conclusions

I personally feel that ever doctor should write a brand with the name of the generic salt in the bracket so that prescription errors goes to minimum. Also, the Drug Controller of India should release a website where every doctor should be able to find out which drugs are cheapest in the market and yet approved by the Drug Controller of India.

Padma Shri and Dr B C Roy National Awardee and National Vice President Elect India Medical Association