A patently obvious fact : Vanam Jwala Narasimha Rao

A patently obvious fact

Vanam Jwala Narasimha Rao

Millennium Post, New Delhi (27-05-2020)

(Given that generic medicines are just as safe and effective as branded medicines while still being more cost-effective, it is prudent to promote the same for wider healthcare access-Editor)  

The annual pharmaceutical sales turnover in any state including Telangana touches thousands and thousands of Crores of rupees. According to Doctors, the annual expenditures on branded medicines incurred by a diabetic patient and hypertension patient roughly touch around Rs. 10,000 and Rs. 7,500 respectively.  Similarly, a patient treated for serious infection may incur anywhere between Rs. 6,000 to Rs. 10,000 for a minimum of ten days. This is a definite burden on the patient belonging to lower middle class, middle class and even the upper middle-class, whose incomes are low. The only way out for this is, shift from buying Branded Medicines to Generic Medicines.

Available data says, that, the family level disease burden is quite alarming. In every state on an average every family has one case of Diabetes or Hypertension and sometimes both. In every two families at least one case of Cardiovascular Disease is present. In every five families at least one case of mineral and or vitamin deficiency is found. In every three families one illness episode of serious nature per year occurs. Life style diseases like Diabetes, Hypertension, Cardiovascular Diseases like Ischemic, Atherosclerosis and Dyslipidemia are very common. Drugs have thus become a part of average person’s life.

Every Drug has three names namely, Chemical (For example N-Acetyl Para Amino Phenol), Generic (Paracetamol) and Brand Name (Crocin). The generic name is most important of all. It is the official pharmacological name of the active ingredient-Chemical or Biological-in the medicine that produces the curative effect. The brand name is chosen by the manufacturer, usually on the basis that it can be recognized, pronounced and remembered by health professionals and members of the public.

The generic name medicines also contain inactive ingredients, which are used to formulate the active ingredient into a tablet, liquid, cream or other preparation. Medicines containing the same active ingredient, but made by different manufacturers, may vary in appearance. There may be small differences between them, such as color, the amount of time taken for a tablet to be absorbed into the bloodstream etc. These differences are rarely significant, which is why generic and branded medicines are almost interchangeable.

When a pharmaceutical company develops a new drug formulation, it is put through a series of clinical trials in order to gain approval for marketing from the concerned regulatory agency constituted for this purpose by the Government. If the clinical trial results show the new drug to be safe and effective for the condition in question, the regulatory agency approves the drug and gives it a license.

The pharmaceutical company can then market the generic medicine under a brand name with exclusive rights to market for a certain period of time, say, about 10 to 12 years. This is known as a patent, and allows the drug company to recoup the costs of research and development of the new medicine, before other drug companies are allowed to produce it as well. Other drug companies are likely to be able to produce and sell the medicine at a cheaper rate, because the research and development has already been done. However, they must market it under a different brand name, or under its generic name.

A generic drug must contain the same active ingredients as the original formulation. Both generic and branded have same active ingredient. The Strength, dosage norms, route of administration, absorption and curative effect of both products would be similar. One reason for the relatively low price of generic medicines is that competition increases among producers when drugs no longer are protected by patents. Companies incur fewer costs in creating generic drugs and are therefore able to maintain profitability at a lower price.

There is however a huge difference in the price. Branded drug is priced high because advertisement and other promotion expenses are unreasonably high. There is absolutely no relationship between cost of raw materials and the final price.  Incentives to doctors or trade are several times that of actual cost of bare medicine in the final price.

A Generic drug from reputed companies costs a fraction of   branded one.  Generic drugs are subject to same regulations of the governments as for branded drugs in matters of production process, Quality and safety profile. Generic drugs are labeled with the name of the manufacturer or with a non proprietary. Wisdom lies in picking such Generic drugs as against their branded counterparts. Medication becomes cheaper but the treatment quality is not compromised.

Low price does not mean low quality since Drug Control Authority requires that generic drugs be as safe and effective as brand-name drugs. To ensure this, same checks and monitoring on production process are followed. These are produced by highly reputed Companies. Generic drugs work as fast and as effectively as the original brand-name products. The side effects are also same as in case of branded one and most people make the brand to generic transition smoothly.

Indian Medical Council Regulations prescribe that every physician should prescribe drugs with generic names legibly and preferably in capital letters and he or she shall ensure that there is a rational prescription and use of drug. The MCI or the appropriate State Medical Councils have been empowered to take disciplinary action against a doctor for violation of the provision of the aforesaid Regulations.

The Ministry of Health and Family Welfare has taken various regulatory measures to promote and ensure the quality of generic medicines. Generic drugs should have been in the limelight, better than at present, after Prime Minister Narendra Modi announced that the government will make it compulsory for doctors to prescribe generic drugs. Unfortunately, the scenario is not that bright and not on the expected lines.

            For instance, in whole of Telangana there are just about 100 generic medical shops spread over 23 districts, including seven in twin cities which are known as Jeevandhara or Janaushadhi Medical Shops. Similar is the situation in other states too. They are not in proportion to and commensurate to the requirement of people.

Why not everyone is advised, counselled and educated to use generic rather than the branded medicine by implementing the law more strictly and save the purse and protect the health of people? Why not more and more generic medical shops are licensed and opened across the length and breadth of the country?