THE COST OF CHEAP DRUGS

Why in the News?

Lack of information about effects of unbranded generic medicines hampers patients’ freedom of choice.

Generic Medicines:

1. As per FDA, “A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use”.
2. A generic medicine can act as an equal substitute for its brand-name counterpart.
3. A generic drug may have minor differences from the brand-name product with respect to different inactive ingredients. 
4. The lost cost factor of Generic drugs is because of abbreviated pathway i.e.,
   1. Branded drugs will have patent protection only for a few years,
   2. After the expiry of which other pharma companies can manufacture the same drug.
   3. The generic drugs so produced do not undergo animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. Hence, the less cost-factor.

The spectre of big bad pharma:

1. Manipulate trials
2. Get temporary monopolies through patents and other means.
3. Bribe doctors and harm patients. 
4. Tax evasion
5. Spurious and substandard drugs
6. Non-adherence to temperature
7. Lack of other quality controls.

Cost of drugs:

1. Broadly, medicines are of three types: 
   1. Still on patent and therefore, a brand
   2. Off-patent and generic, but nonetheless produced by a reputed company, with a brand
   3. Off-patent, generic and unbranded.
2. Out of the 8,500 MSME units, we know only 2,000 are GMP (good manufacturing practices)-compliant, though adherence to GMP has been mandatory since 1988.
3. GMP are needed not only for exports, but for the domestic market too.
4. Mashelkar Committee, 2003:
   1. Extent of substandard drugs varied from 8.19 to 10.64 per cent
   2. Extent of spurious drugs varied between 0.24 per cent to 0.47 per cent.
5. Asymmetric information on drugs provides no true freedom of choice.

About:

Guidelines for doctors to prescribe generic drugs:

1. Doctors can only write the generic names of the medicine on the prescription instead of a brand name.
   • For instance, Paracetamol has to be prescribed for fever, instead of Dolo or Calpol.
2. The generic names have to be written legibly and shall avoid prescription of any unnecessary medications and irrational fixed-dose combination tablets.
3. This mandate can be relaxed only for or medicines with,
   • Narrow therapeutic index (drugs where a small difference in dosage may lead to adverse outcomes)
   • Biosimilars (a different version of biologic products that are manufactured in living systems) and,
   • Similar other exceptional cases.

What is the intend behind the guidelines issued?

1. Lower healthcare costs
   • Generic medicines on an average tend to be 30%- 80% cheaper than the branded versions.
   • It helps in reducing the Per Capita Out-of-Pocket Expenditures related to healthcare in a substantial way.
2. Increased treatment adherence by patients.
3. It shall also encourage people to purchase unbranded quality medicines from “Jan Aushadhi kendras” set up by the GoI.

Why are the doctors protesting?

1. Uncertainty about the quality of generic drugs
   1. Quality control of drugs is very weak especially with regard to generic drugs in India.
      1. Around 3% of all medicines tested over the last three years, including generics, branded generics, and branded medicines were of poor standard quality.
   2. Prescription of drugs without assured quality would be detrimental to health of patients and may not assure recovery of the patient which can lead to,
      1. Hampering of the Doctor’s reputation.
      2. Can lead to increase in violence against doctors by the kin of hospitalised patients.
2. It promotes use of brands with good profit margin in the pharmacies as doctors don’t write a specific brand name, any medicine with the relevant active ingredient in the pharmacy stocks will be given.
   1. The pharmacy usually stocks branded medicines instead of generic ones as the latter has low profit margin.
   2. If generic drugs are unavailable, the responsibility of substitution is shifted to pharmacists. This will only promote good profit margin brans irrespective of it being good or bad.
3. Prevalence of medicines that have skipped the mandatory approval process that was rolled out few years ago.
   1. Only a few years ago, it was made mandatory for companies making generics to carry out
      1. Bio-equivalence studies - to ascertain that the generic drug elicits the same response as a branded version.
      2. Stability studies- to demonstrate the quality of the drugs’ variance over a period under specific environmental conditions.

Way forward:

1. Government should ensure uniform quality across all the generic drugs.
2. Stringent regulatory requirements for the quantity of the drug and the permissible impurities in its generic version as given by United States Food and Drug Administration in its Orange Book.

The Orange Book provides information of approved drug products with therapeutic equivalence evaluations on a monthly basis.

3. A legislation to ensure compliance in generic drug manufacturing and testing has to be formulated instead of guidelines.
4. Experts formulating medical education curriculum shall include emphasis in patient expenses and use of generic medicines as they are adequately emphasized during their UG and PG training.
5. 4E” (Education, Engineering, Economics, and Enforcement) methodology for promoting generic drug utilization and development in Europe can be adopted in India as well.