Critically analyze the Draft Pharmaceutical Policy 2017 suggestion to improve the quality of drugs in India?
Published: August 29, 2017
Department of Pharmaceutical recently circulated Draft pharmaceutical policy. The policy aims to cover a range of issues including the quality of Indian drugs, the time taken for drug approval.
Policy intends to reduce reliance on China & to encourage domestic production of active pharmaceutical ingredient(API), as it affects country’s drug security. As per the suggestions, all APIs that can be made indigenous should attract high customs duty, also in government contracts, locally produced APIs formulations should get preference. However, the major problem is that if formulations with domestic API are expensive, then they may become uncompetitive.
For quality control, policy proposes a stricter mechanism for approvals for generic drugs, however, approvals will be quick. As per policy draft, prescription of drugs should be as per generic and not brand names. However, this proposes an exemption to fixed-dose combinations and patented drugs. Again, exempting fixed-dose combinations may create new complications.
On price controls, the draft policy proposes changes to the drug pricing regulation by separating the government and the regulator’s role. Another matter of concern is regarding the NPPA as policy suggests to change its constitution and structure entirely, which may curb NPAA autonomy.
If the government imposes restrictions & put limits on pricing power, and on how business is done, it may limit industry’s growth and profitability.
If the government can assure subsidized medicines to low-incomes patients, the relatively better off can pay market-determined prices. This will be a win-win for government and the private entrepreneur.
Model Questions Category: 048 - Social Sector Services Education Human Resources