India issues new guidelines on nanomedicine

[NEW DELHI] India’s bid to manufacture nanopharmaceuticals — which promise safer and more efficient use of existing medicines — has gained strength with the publication of new guidelines last week (24 October). 

Known as ‘pharmacy to the world’ for its wide range of affordable generic drugs, India has begun research and manufacture of next generation nanopharmaceuticals that make it possible to target drug delivery at specific sites of the body and enhance bioavailability which limits toxicity while improving efficacy.

The new guidelines, says Harsh Vardhan, India’s minister for science and technology, as well as health and family welfare, will help ease research for the clinical testing and commercial manufacture of nanomedicines “while highlighting India’s capability for newer product development using nano and emerging technologies for health care”.

“Nanopharmaceuticals are expected to capture a sizeable segment of the current market for medicines and the new guidelines will help the Indian pharmaceutical industry to utilise the existing strength of Indian scientists to develop novel nanoformulations”

V.G. Somani

Vardhan explains that as a medical doctor, he would naturally like to be able to treat patients with more effective and safer drugs. “I appreciate that nanoformulations have higher efficiency and lower side effects than conventional drugs,” he says.

Nanoparticles are generally smaller than human cells but larger than biomolecules, and this allows nanopharmaceuticals to be designed to act on specific areas of the body. This feature is of particular use for treating cancer where it is risky for surgical resection or chemotherapy to prevent metastasis (spread of cancer to other organs).

Take the anti-cancer drug taxol, a plant alkaloid obtained from the bark of the yew tree and long used for the treatment of breast, ovarian, lung, bladder, prostate and other cancers. Taxol was effective but its side effects — as with most chemotherapeutical agents — were drastic and typically included hair loss, anaemia, joint-pain, diarrhoea and nausea.

So when the Indian pharma major Panacea Biotec came up with its version of nanoparticle albumin-bound (NAB)-Paclitaxel under the generic brand name NAB-PacliAll, using ‘particle-size optimisation’ nanotechnology to reduce side effects, the new formulation proved far more acceptable than Paclitaxel, the conventional drug for cancer treatment.

“Particle-size optimisation helped stop active pharmaceutical ingredients, that cause hair loss in women being treated for breast cancer, from getting to hair follicles,” says R.D. Karan, vice-president at Panacea Biotech, which is among India’s top 60 pharma companies.

Karan said the new guidelines, formulated after wide consultations, will provide transparent, consistent and predictable regulatory pathways which will help manufacturers, importers and other stakeholders involved in the research and development of nanopharmaceuticals.

According to V.G. Somani, India’s drugs controller-general, the main difficulty with putting together evaluation guidelines for nanomedicines stems from the fact that they have physical, chemical and biological properties which are altogether different from the bulk materials they are produced from.

The new guidelines define nanopharmaceuticals and incorporate specific scientific evidence requirements for their approval as well as strategies for pharmacovigilance, methods of risk assessment, safety testing and data quality.

“Nanopharmaceuticals are expected to capture a sizeable segment of the current market for medicines and the new guidelines will help the Indian pharmaceutical industry to utilise the existing strength of Indian scientists to develop novel nanoformulations,” Somani says.

This piece was produced by SciDev.Net’s Asia & Pacific desk.