Upcoming regulatory reforms affecting Indian pharma. Prepared in association with Nishith Desai & Associates, a leading law firm in India, this is an extract from The Pharma Legal Handbook: India, available to purchase here for GBP 75.
1. Are there proposals for reform or significant change to the healthcare system?
The Government has recently released draft regulations that propose to create a streamlined system of licensing e-pharmacies and governing the sale of drugs online. The rules grant legal recognition to e-pharmacies and prescribes duties with respect to handling of prescriptions and protection of sensitive patient data. It states that while the data shall be kept confidential, it may be shared with the Government for public health purposes. However, e-pharmacies will not be permitted to sell psychotropic drugs i.e. drugs in Schedule X. Any complaints against e-pharmacies can be made to the State Drug Licensing Authorities.
Companies Marketing Products liable for quality
The D&C Rules have been amended with effect from March 01, 2021 such that the companies marketing the drugs will be held responsible in addition to the manufacturer. Currently, big pharmaceutical companies escape liability with respect to the quality of their drugs by contracting out manufacturing to third parties. This amendment seeks to incentivize big pharmaceutical companies marketing the drug to ensure that the manufacturer of the drug being marketed is in compliance with the law.
2. When are they likely to come into force?
Comments from the public were accepted in respect of the e-pharmacy regulations and the rules are in the process of being finalized.
The amendment that seeks to make marketing companies liable for product quality will come into effect on March 31, 2020.