Teena Thacker

India is streamlining access to rare disease drugs by waiving local clinical trials for some medications. The drug regulator is expediting approvals, facilitating imports, and prioritizing testing to ensure faster availability for patients. This includes fast-tracking global trial approvals and waiving trials for certain advanced therapies and drugs used in pandemics or for defence.

A government committee is working to compensate patients affected by faulty Johnson & Johnson hip implants. The committee aims to locate more patients eligible for compensation through advertising and will soon evaluate claims. J&J has paid 246 patients, but disputes the government's proposed compensation formula, preferring a lower amount.

The drug regulator had earlier this year formed an expert panel to evaluate medicines which can become OTC from prescription after pharmaceutical companies approached the regulator to make their drugs OTC, a person said.

India's drug pricing regulator, NPPA, is increasing scrutiny of pharmaceutical companies seeking price exemptions. The NPPA is collaborating with the Indian Patent Office to evaluate applications, including those from Intas Pharmaceuticals and Biological E, under DPCO, 2013. These companies claim their new drugs, developed through indigenous research and patented in India, qualify for a five-year exemption from price controls.

India is developing a framework for over-the-counter (OTC) drugs, potentially allowing some prescription medications to be sold in general stores. A sub-committee is reviewing international guidelines and considering amendments to the Drugs and Cosmetics Act to regulate OTC drug distribution, marketing, and consumption, aiming to improve access while preventing misuse.

The department of pharmaceuticals (DoP) reprimanded AbbVie Healthcare India for unethical marketing practices involving over ₹1 crore spent on foreign vacations for 30 doctors under the guise of conferences in Monaco and Paris. The Central Board of Direct Taxes (CBDT) and National Medical Council are to evaluate the company's tax liability and take action against the healthcare professionals involved.

AbbVie Healthcare India has denied accusations of unethical marketing by the Department of Pharmaceuticals, asserting their compliance with applicable laws. The DoP flagged AbbVie for breaching the Uniform Code for Pharmaceutical Marketing Practices by sponsoring luxurious trips for doctors, leading to a probe into the company's tax liabilities and potential professional repercussions for the involved healthcare practitioners.

The Karnataka High Court has provided temporary relief to pharmaceutical companies by directing the government not to act against firms producing nutraceuticals in drug-licensed units until the next hearing. This follows the industry's challenge to Schedule M, which prohibits manufacturing non-drug products in drug facilities.

Mankind Pharma has partnered with Innovent Biologics to bring sintilimab, a PD-1 immunotherapy, to India. The drug treats various cancers and improves patient access to innovative therapies. Mankind Pharma will manage registration, import, marketing, and distribution, while Innovent will handle manufacturing and supply. This collaboration aims to transform oncology care in India.

The government has established a committee to create rules for prosecuting chemists and retailers selling spurious drugs. This initiative aims to tackle the issue of substandard drugs being sold despite valid invoices from other states. The committee's report is expected within one month.