Generic Medicine – What is it?

Although in India, the MCI did not officially define the term generic medicine/drug, the US FDA (United States Food and Drug Administration) has issued a definition that describes a generic drug/medicine as being identical, or bioequivalent, to a branded drug in dosage form, quality, strength, safety, route of administration, intended use and performance characteristics. Even though chemically, generic drugs have the same composition as their branded counterparts, they are usually sold at considerable discounts from the price of theirĀ  branded counterparts. In short, a generic drug could be described as one that is named after its chemical constituent, such as Paracetamol which is the generic version of branded drugs such as Crocin and Calpol. Dr. Ashutosh Pattnaik, DNB, Radiation Oncology, Kamla Nehru Memorial Hospital, Allahabad, further explains that with generic drugs a consumer will be given chloroxylenol, instead of Dettol or Savlon at the medical store. This is because chloroxylenol is the generic variant of Dettol and Savlon.

Generic Drugs over Branded Ones

The differences between generic drugs and branded drugs is quite straightforward; generic drugs are different from branded ones in respect of theĀ  manufacturing processes involved, the marketing and branding strategies adopted. With branded medication, their manufacturers tend to spend much more on the above mentioned parameters due to various reasons, resulting in them being priced higher. With generics, however, this expenditure is much lower allowing them to be priced much lower.

Accessibility

Can generics be easily accessed? Experts we spoke to were divided in their opinions. While a few doctors advocated the need for an increased number of medical stores retailing generic drugs all over the country, others felt that almost all generic drugs were freely available with all pharmacists and medical stores. Some opined that increased demand for generics would cause a corresponding expansion in the supply.

Cost Control Measures

As discussed previously, the main parameters that determine the cost of a drug are the manufacturing costs and the expenditure on marketing and promotion. However, if the same drug is available at widely varied prices in the market, how is a consumer to determine which one to choose? Or does this choice then vest with the pharmacist in question? Dr. Sunil Sharma, General Physician; Head of Emergency, Madan Mohan Malviya Hospital, Delhi, is of the view that the power does shift to the pharmacists. He also believes that the variations in pricing with generic drugs is an issue that requires checking and regulation. He feels that there needs to be some kind of uniformity in the pricing of generic medication.

Quality Issues

The issues relating to quality can be explained through an example; if the banded version of a drug is priced at Rs. 200, while its generic versions are priced between Rs. 20 to 250, how is a consumer to decide which of the generics available adheres to proper quality and standardization laws and which did not?

An orthopedic surgeon located in Delhi, who requested that he not be named, said that this was a good step but cautioned that there were many loopholes that had to be plugged before the directive could be implemented all over the country. Further, the doctor stated that at the moment it was difficult to ensure that the pharmacist was not selling substandard medication to meet his margin. He advocated that the Central Drugs Standard Control Organization put a system in place so that all the drugs available in the market could be monitored. A stringent system would negate the possibility of substandard drugs reaching the consumers.

The MCI directive is not mandatory and doctors have the freedom to prescribe branded medication. However, it clearly advocates that medical professionals write the name of the chemical compound that a drug contains along with its brand name so that the patient is better informed. Summing up the interviews with experts in the field, the following issues appeared predominant and were unanimity stressed on by all:

– Low-priced drugs are a necessity and should be made available to all.

– Quality should never be compromised on for anything.

– Generic drugs should also be prescribed for in patients along with out patients.

– The government machinery should actively work towards inculcating confidence in the minds of the people regarding the use of generic drugs.

– The use of low-priced, high-quality, generic consumables and tools should be advocated.

 

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