National Pharmaceuticals Pricing Authority (NPPA) is an organization of
the Government of India authorized to fix/revise the prices of
controlled bulk drugs and formulations, and to enforce prices and
availability of the medicines in the country, under the Drugs (Prices
Control) Order, 1995 [1]. It is commendable that so far a total of
650-odd formulations have price caps. Of the total healthcare spending,
70% is on medicines. In India this cost is mostly borne by the patients.
Controlling drug prices by administrative fiat may appear to be a
correct initiative, but in reality it may not be so. We share our
concern regarding impact of drug control on pediatric formulations.
Paracetamol oral formulation (125 mg/5 mL) is under
price control. Several of the leading manufacturers have changed
formulation to 120 mg, 150 mg, 500 mg per 5 mL or to 250 mg per 7.5 mL
to overcome the price control without any drop in prices.
Amoxicllin-clavulanic acid combination (Syrup 200+28.5 mg, Tablet
500+125 mg) is under price control. Several manufacturers have increased
cost of other formulations (tablet 250+125 mg, drops 80+11 mg) as a
compensatory process. Chlorpheniramine maleate (2 mg/5 mL), an
anti-histaminic preparation, in isolation is difficult to procure in the
market. Majority of manufacturers have clubbed it with a decongestant,
mucolytic, antitussive or antipyretic agent to avoid price control.
Cetrizine (5 mg/5 mL) is readily available as 2.5 mg/5 mL or in
combination with a mucolytic agent, thus avoiding price control.
Salbutamol (2 mg/5 mL) has almost disappeared from the market once it
came under price control. Majority of the manufacturers withdrew the
molecule and changed the formulation to levo-salbutamol and modified the
brand name. This led to a doubling of the cost. This is also true for
respiratory solution for use in nebulizer. Several antibiotics (e.g.
cefixime, azithyomycin) are also being marketed in strengths that are
different from those under price control.
It is clear that the companies are modifying the
strength, composition or format of the drug to avoid price control. This
defeats the purpose as the drug either is difficult to procure or
prescribe as laid down in the drug control list. There is no regulation
on manufacturing a drug in various strengths or in combinations, which
allows the companies to come with newer formulation overcoming the drug
control. It is also a tragedy that majority of doctors are ignorant
about this process, and there is a need to bring about awareness amongst
the doctors and patients to prefer medicines in the drug control format.
There is an urgent need for professional medical bodies to pressurize
the Government to ensure strict implementation of the drug control;
otherwise the entire purpose of making the medicines available,
accessible, and affordable would be defeated.
