Two plants of Emami Limited, located at Vapi and Masat in Gujarat, producing range of its healthcare portfolio products under the brand name of Zandu, have been accredited with WHO-GMP and Certificate of Pharmaceutical Products (CoPP) for more than 40 Ayurvedic products with a validity for 3 years.
India has almost 9,000 manufacturing units of Ayurvedic products out of which only a handful of companies have achieved this quality benchmarking of WHO-GMP.
After receiving WHO-GMP with CoPP in 2017 for 11 products under the Zandu brand, Emami has received the same for its two manufacturing units and more than 40 products under the Zandu umbrella in 2020.
As per World Health Organization (WHO), about 80% of the global population prefers to use traditional medicine for their health. Considering a wide variation in knowledge level and quality consciousness in this regard across nations, WHO, after due cross-country deliberations, has identified three attributes of quality, safety and efficacy and issued a detailed guideline of Good Manufacturing Practices (GMP) to ensure an uniform quality benchmark for these traditional medicines.
Accreditation of the manufacturing facility and Certificate of Pharmaceutical Products (CoPP) are the two steps in the WHO-GMP guideline after stringent inspection and review of Processes, SOPs, Quality Management Systems and other important documents.
Harsha V. Agarwal, Director, Emami Limited said, “Many countries have provided official recognition to AYUSH but WHO-GMP and CoPP are mandatory for registration. It is due to this reason that many Indian companies despite having good number of products are not able to export ayurvedic healthcare products outside India. Issuance of WHO GMP to the Emami units and CoPP for more than 40 such products under our Zandu brand umbrella, is a recognition and global testimony of the superior quality, safety and efficacy of our 100 plus year old brand. Besides authenticating the quality of our Zandu brand of Ayurvedic products, this certification also provides Emami a unique competitive edge for exporting them and realizing the potential of the global awareness of AYUSH to take its traditional natural goodness to a wider world-wide consumer base.
In the wake of COVID pandemic, the world has noticed the benefits of Indian Ayurvedic medicines in enhancing immunity and lowering mortality in India compared to other nations afflicted with this virus. Boosted by the patronage of the Government of India, the efficacy of AYUSH products have received the world’s attention triggering a higher global demand and opening a wider export opportunity. In this context, WHO-GMP and CoPP are extremely important global quality benchmarking and facilitators in realizing the export potential of AYUSH products.
In India, WHO-GMP and CoPP for individual products is granted by Drugs Controller General of India after joint inspection of the unit, evaluation of manufacturing facility and quality of raw material and product by representatives from CDSCO (Central Drug Standards Control Organization), Ministry of Health & Family Welfare as well as Ministry of AYUSH.