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The Indian government has imposed a ban on the manufacture of drugs by non-state actors, a move that has prompted questions about how much will be saved by scrapping the current system.
The ban has been implemented on four categories of pharmaceuticals – generic, branded, specialty and patented – that were produced between 2014 and 2019 by three pharmaceutical companies: ULTRAGENIX, MEDIAS, and MEDIISERV.
The Government of India said the ban will affect the production of over 2.5 lakh drugs and will save $1.3 billion in annual cost.
“The Government of the Republic of India has taken the decision to ban the manufacture and distribution of drugs and biological products (BPs) by non state actors in accordance with the Government of Pakistan Ordinance,” the Ministry of Health said in a statement on Friday.
“This will also be a boon for patients in India.
In addition, the ban on manufacturing and distribution will ensure a reduction in the amount of BPs in the country,” it said.
The moratorium applies to generic drugs and branded medicines, branded pharmaceuticals and pharmaceuticals manufactured under the Indian Pharmacopoeia Act, 2016.
The new policy applies to all generic drugs manufactured after January 1, 2021, and branded pharmaceutical products manufactured after April 1, 2022.
The moratorium will come into effect from April 1.
The government has said it will not issue new licenses for any drug produced by nonstate actors.
The National Food Security Act, 2015 mandates that only the government can issue new licences for the manufacture, sale and distribution, of BPSs.
The act also allows for importation of BPTs into India and for import of BPOs into the country.
The move comes as the Indian pharmaceutical industry has been struggling to survive after the government scrapped the requirement that the manufacturers of generic medicines, BPs and BPO products submit to a process called the Pharmaceutical Products Regulatory Authority (PMRA) process.