In a reversal of turns, Orphan Drugs manufacturers in India may likely get some much needed relief from the proposed Rs 15,000 crore production linked incentive (PLI) scheme, according to latest news reports.
This is a key milestone for the Indian Rare Disease fraternity including Indian Organisation for Rare Disease, an umbrella organization representing interests of all rare disease patients, patient support groups, health policy advocates and health care providers for rare diseases in India.
The new proposed PLI scheme of Rs 15,000 crore incentive – which is still in the process of getting a final shape – will be part of an investment package that the government of India is likely to unveil to attract domestic and international drug manufacturers to increase production of drugs including those meant for Rare Disease patients.
This is in addition to Rs 6,940 crore PLI scheme to boost local manufacturing of bulk drugs and another Rs 3,420 crore PLI scheme for medical devices, the news story notes.
Under the proposed incentive scheme as reported by Medical Buyer, drug manufacturers may avail the government support under the following three categories:
CATEGORY 1:
Biopharmaceuticals | Complex Generic Drugs | Patented Drugs or Drugs Nearing Patent Expiry | Cell Based or Gene Therapy Products | Orphan Drugs | Special Empty Capsules | Complex Excipients
CATEGORY2:
Active Pharma Ingredients (APIs) /Key Starting Materials (KSMs) and / Drug Intermediaries (DIs)
CATEGORY3:
Repurposed Drugs | Auto-Immune Drugs, Anticancer Drugs, Anti-Diabetic Drugs, Anti-Infective Drugs, Cardiovascular Drugs, Psychotropic Drugs and Anti-Retroviral Drugs | In-vitro Diagnostic Devices (IVDs) | Phytopharmaceuticals | Other Drugs not manufactured in India | Other drugs as approved.
This is a welcome sign of sorts as Indian Organisation for Rare Diseases (IORD) has been relentlessly taking up this cause before the government fora and pharmaceutical industry bodies as part of its advocacy on Rare Disease patients’ rights in India.
Recently, this point was vociferously raised by IORD CEO & President Prof Ramaiah Muthyala at a national level webinar on “NEED FOR ESSENTIAL MEDICINES FOR RARE DISEASES” organised on August 1.
National representatives of all top pharmaceutical industry associations including BDMA, IPA, IDMA, FOPE & OPPI including Dr VG Somani, DCGI, MoH & Family Welfare, India, attended this webinar.
