To boost herbal products exports, industry bats for GMP compliance by Ayurvedic drug makers

Kerala Ayurveda | N Murali Krishna has resigned as CFO and COO of the company.

The herbal drugs industry, backed by the Union government, is asking companies with an annual turnover of Rs 50 crore to mandatorily opt for the World Health Organisation's good manufacturing practices (GMP).

This comes amid concerns that the majority of Ayurvedic drug makers in the country have quality issues. Government data shows that only about 30 companies out of about 9,000 have manufacturing plants certified under WHO GMP.

There are about 500 Ayurvedic drug makers in India with an annual turnover of more than Rs 50 crore each.

The move is aimed at boosting the export of herbal medicines from India. In 2020-21, Ayush (Ayurveda, Unani, Sidhha and Homeopathy) products worth $539.57 million were shipped overseas compared to $425.80 million during the previous financial year.

“Our main targets are to ensure that herbal products manufactured in the country are of the highest quality and maintain international standards and it’s a pity that most drug makers as of now do not pay much attention to quality control despite the government guidelines,” said an official of a top herbal drug maker who is part of several committees in the Ayush ministry.

WHO maintains that GMP is a system for ensuring that products are consistently produced and controlled according to prescribed quality standards that minimise risks such as unexpected contamination which could damage health or even cause deaths, and to avoid incorrect labelling on containers, which could mean that patients receive the wrong medicine or insufficient or too much active ingredients, resulting in ineffective treatment or adverse effects.

It also points out that most countries only accept the import and sale of medicines that have been manufactured to internationally recognised GMP. Governments seeking to promote their countries' export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements, says the body.

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Tanuja Manoj Nesari, director of the All India Institute of Ayurveda, said that such an initiative will increase the confidence of users in Ayurveda by ensuring quality and safety of the medicines. “It will happen through regulating the supply chain, improving in-process quality standards and standardising the finished products,” she said.

According to Manisha Mishra Goswami, medical adviser with Charak Pharma, an Uttar Pradesh-based Ayurvedic drugs firm, while the traditional medicine system has seen increasing acceptance globally, there is a need for the Ayurvedic industry to adopt GMP to ensure safe and effective medicines of the highest quality standards.

Goswami said Ayurvedic medicines are largely herbs-based and are considered safe and effective but they have a large number of active compounds, which vary with geography, season, cultivation and handling during medicine making, which affects the quality of the final product.

GMP, on the other hand, guarantees that good quality medicines are produced and these regulations for Ayurveda manufacturing units will help validate production and testing procedures to ensure that the raw materials are authentic, free of contaminants, that the factory premises conform to the norms, the staff is well trained and hygiene at each step is maintained, she said.

“Implementation of GMP guidelines assures that product quality is consistent for every batch so that the consumers get safe, effective and quality-controlled products every time,” Goswami said.

As per government data, exports of Ayurveda, yoga, naturopathy, Unani, Siddha, Sowa-Rigpa and homoeopathy products from India grew 27 percent in 2020-21 over the previous year and imports grew by 28 percent over the same period.

The market size of Ayush products grew to $18.1 billion between 2014 and 2020, figures by the Ayush ministry also show.

“Having no FDI (foreign direct investment) limits, this sector has massive potential for exponential growth, especially in times of public health crises,” said Pradeep Multani, president of the PHD Chamber of Commerce and Industry, who is also director of Multani Pharmaceuticals, a manufacturer of Ayurvedic and Unani products.

With a strong base of the ancient system and significant rise in the use of Ayurvedic medicines, India is poised to be a global leader and is projected to see an impressive growth over the course of the next five years, he said.