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 USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
Draft Clinical Trial Rules, 2018 (“Clinical Trial Rules“)
The Central Government has proposed to supercede the part and schedule of the D&C Act dealing with clinical trials, and introduce the Clinical Trial Rules with new procedures for conducting clinical trials in India. The rules bring in a requirement to pay interim compensation in case of death or permanent disability of a subject during a clinical trial. Sixty per cent of the compensation payable (based on the prescribed formula under the Clinical Trial Rules) must be paid within 15 days from the date of receiving the opinion of the ethics committee. The interim compensation cannot be recovered irrespective of whether the death or permanent disability was caused by the clinical trial. The rules are in the process of being finalized by the government after receiving comments from various stakeholders.
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
A proposed amendment to the D&C acts seeks to hold the companies marketing the drugs 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 incentivise big pharmaceutical companies marketing the drug to ensure that the manufacturer of the drug being marketed is in compliance with the law.
Draft Digital Information Security in Healthcare Act (“DISHA“)
The Ministry of Health and Family Welfare a draft legislation aimed at regulating and protecting digital health data called the Digital Information Security in Healthcare Act (“DISHA”). The ministry had invited comments from the public with respect to the draft, which is expected to be revised based on feedback and finalized soon. DISHA is expected to improve the existing data protection regime for personal health data in electronic form by introducing new provisions for privacy, confidentiality, security and standardization of health data, and provides for the establishment of a National Digital Health Authority, a standard setting body, as well as Health Information Exchanges, which will act as a public repository of Digital Health Data.
2. When are they likely to come into force?
- The new clinical trial guidelines are currently being revised and the CDSCO expects to release them in a few months.
- The e-pharmacy regulations have been published and comments are being accepted from stakeholders.
- The amendment that seeks to make marketing companies liable for product quality has been approved by the Drugs Technical Advisory Board (“DTAB”), the apex body on regulating technical matters in respect of drugs.