Mentor’s Comment

• Define Generic Drugs
• List reasons why they are not being used as widely as they should have been
• Suggest reforms.

Answer:
India is the leading manufacturer and exporter of generic drugs. Also there is an increased push by the government for generic drugs, for affordable healthcare. Recently, the Prime Minister has announced that prescription of medicines by their generic names will be mandatory. This shows the importance of generic drugs not only in India but in the global healthcare system as well.

What is a generic drug?

A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use.
The term may also refer to any drug marketed under its chemical name without advertising, or to the chemical makeup of a drug rather than the brand name under which the drug is sold.
The Indian government began encouraging more drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970.
The Patents Act removed composition patents for foods and drugs, and though it kept process patents, these were shortened to a period of five to seven years.
The resulting lack of patent protection created a niche in both the Indian and global markets that Indian companies filled by reverse-engineering new processes for manufacturing low-cost drugs.
The code of ethics issued by the Medical Council of India in 2002 calls for physicians to prescribe drugs by their generic names only.

Present status of drug availability and pricing in India:

At least 90% of the Indian domestic pharmaceutical market, of ₹1,00,000 crore and more, comprises drugs sold under brand names. There simply are not enough generic name equivalents of branded medicines sold.
About half the market Rs. 50,000 crore and more—is for fixed-dose combinations (FDCs) of drugs, a further half of them irrational.
Many FDC drugs contain even eight or nine medicines. To write, and remember, the constituents of FDC drugs in generic names is impractical, considering that there would be thousands of FDC brands.
A combination drug is a fixed-dose combination (FDC) that includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.
Even if the doctor manages to write a prescription in generic names for single-ingredient drugs, pharmacists will sell the brand that maximises their commission and will in all likelihood not stock the less costlier but equivalent brand or generic medicine that is as good. This defeats the basic intention of making medicines affordable for consumers.
Prescription by generic names merely shifts the focus of the pharmaceutical industry’s unethical drug promotion to the pharmacist; away from the prescriber, and resulting in business as usual.
Medicines will continue to account for anything from 50% to 80% of treatment costs.

Challenges in generic drugs in India:
The issue in India is not about expensive brand name drugs versus cheaper generics, as in the West, but one of quality drugs versus suspect quality drugs.
Branded generics are also generics with a brand name, plus the quality assurance from well-known companies like Cipla, Sun or Dr Reddy’s. Doctors have come to trust these companies and their brands over time.
Indian pharma’s field force numbering nearly one million medical representatives have done a good job of building this trust in their companies and brands.
It is simply not possible for doctors to transfer this trust to generics, manufactured by unknown companies.
The entire issue of cheaper generics is based on the premise of measurable and enforceable assurance about quality through bio-equivalence tests and other globally mandated parameters. In the absence of that, the generics-only diktat is a non-starter.
In the absence of an international standard drug regulatory mechanism like the USFDA, Indian doctors have to rely on the reputation of companies like Cipla, Sun and hundreds of others who have demonstrated their commitment to quality over time and become trusted names in the eyes of doctors and patients.
Also, Indian branded generic companies have been innovative in terms of drug delivery systems to improve absorption, reduce side-effects, thereby increasing the efficacy of the drug.
These novel drug delivery system (NDDS) drugs are available in all category of drugs from ordinary mouth dissolving pain-killers for quick results to complex diabetes drugs that are released into the blood in a steady stream to ensure better blood-sugar control with lesser chances of hyperglycemia – one of the dangerous complications of taking diabetes medicines.

Way forward:
The Medical Council of India (MCI), in an amendment to the Code of Conduct for doctors in October 2016, has recommended that every physician “should prescribe drugs with generic names legibly … and he/she shall ensure that there is a rational prescription and use of drugs.”
How the MCI is going to ensure rational prescription and use, without a framework to measure the same, should be looked into seriously.
Rational use and prescription depends on the doctor, the pharmacist, the regulator, and the consumer.
Prescription-only medicines must not be available freely over the counter; doctors and their professional bodies along with regulators must ensure there is no misuse of antibiotics and critical drugs; and the removal of all irrational/harmful/useless medicines, both FDCs and unscientific single ingredients, must be ensured.
Practical guidelines for rational use and prescription audit of medicines must be developed and implemented seriously by all doctors. Branding of off-patent drugs needs to be discouraged as is the practice in well-regulated countries.
The Hathi Committee Report (1975) too had recommended debranding.
Price control of an enlarged list of essential and life-saving drugs is a must as was mandated by the Supreme Court in 2003.
The current market-based price mechanism of the Drug Price Control Order (DPCO) 2013 is a travesty and has resulted in ceiling prices that allow 2,000% to 3,000% (and in some cases, 10,000%) margins. This needs to be replaced by the cost-plus method of ceiling price fixation of the DPCO 1995.
The number one priority must, thus, be the replication of the Tamil Nadu/Rajasthan model of free medicines in all states, and pharmaceutical PSUs must be re-energised and reinvented instead of the government disinvesting in them.
Since the issue is also about quality, the government must put in place reforms that will make it mandatory for drug manufacturers in India to adhere to globally accepted standards.
The strategy can be two pronged with an increase in the capacity of existing testing laboratories and opening up of new laboratories in government colleges.
A time bound plan to make generic prescriptions mandatory will also prepare Indian pharma’s vast supply chain of 800,000 wholesalers and retailers to get used to the new initiative progressively. India’s 800,000 retailers have thrived because it is a profitable high-margin business.

The Government of India has championed setting up Jan Aushadhis, which are pharmacies selling only generic name medicines to the extent possible, giving preference to pharmaceutical public sector undertakings (PSUs) too. This is a step in right direction and the solution to the problem of branded versus generic lies in strengthening the existing drug regulatory and quality control structure.