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Lack of regulatory clarity hampers growth of effervescent products in India
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Laxmi Yadav, Mumbai
December 03 , 2021
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Effervescent is less explored dosage form in India due to lack of regulatory clarity with regard to approval process of effervescent product manufacturing and higher capex for plant set up.
“In India there are only four GMP compliant manufacturers of these products. 6-8 manufacturing units producing effervescent products concentrate on nutraceuticals than other categories which may be due to discouragement at regulatory levels for effervescent products and innovations,” said Pradeep Garde, managing director, Scitech Specialities Pvt Ltd and Scitech Healthcare Pvt Ltd.
The country’s approved FDC list of drugs and supplements does not include any effervescent product. Indian Pharmacopoeia does not contain any effervescent product. On the other hand, USP contains 5 effervescent products and BP/EP contains 7 effervescent products.
“Hence Indian manufacturers planning to start production of effervescent products have to submit an application on Form 44 for permission of new drug approval under the provisions of Drug and Cosmetics Act 1940 and Rules 1945,” said Garde.
There are limited manufacturers of effervescent products in the world due to stringent processing requirements. Globally there are a total of 115-120 manufacturing units of these products. Germany, Italy, Switzerland account for 48 per cent of total global production of effervescent products, he added.
Talking about development of effervescent products in the country, he said “In India ENO is the first effervescent product which is available since 1960. Until 1975 there was no new development of effervescent products in pharmaceuticals. Disprin was introduced in 1975. Most effervescent products have been developed in nutraceuticals.”
After 2000, even with renewed interest, there was less product development, innovation and commercialization of effervescent products, stated Garde.
Effervescent products are specified as enhanced bioavailable form than conventional solid orals which leads to quicker onset of action with improved taste and unpalatable actives. Effervescent products allow incorporation of large actives like Strontium ranelate 4mg, metformin 1500 mg etc. which dosages require higher in quantity. They can be formulated as effervescent products as conventional tablets are unsuitable for this sort of formulation.
With this taste and palatability, it becomes an ideal dosage form for geriatric and paediatrics wherein dosing becomes very difficult. This problem could be solved with effervescent products. Although effervescent is considered only for other products, its acceptability for all ages becomes higher due to lesser gastric side effects as solutions which will be ingested will be a buffer solution, he said.
Effervescent formulations are known since 18th century. Initially it was referred to as compound effervescent. It was first commercially available as Seidlitz powders in Germany which was used as saline cathartics. In 1932 the first effervescent tablet—Alka Seltzer was introduced. Development of effervescent products continued to a great extent for supplements rather than pharmaceuticals, he added.
“There were no major developments in pharma effervescent till 1990 and most developments were in supplements. After 1990, there was renewed interest in effervescent technology and product development—may be due to emergence of specialty generics or super generics. Several patents were granted for effervescent products. Europe became the hub of major development and commercialization of these products as against US and Japan,” he stated.
Currently, the estimated global market of effervescent products is USD 7.4 billion with a CAGR of 9 per cent. North America, Europe, Japan, MENA remained major markets of these products while developing markets are India, South Africa, Nigeria, Vietnam, Korea, Thailand, Philippines. Bayer, GSK, Amerilabs, Hermes, E-Pharma are some of the major manufacturers of these products.
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