As the ultimate aim of herbal products is to deliver the goodness of herbs to the consumers, regulations must be framed in consistence with this objective. A herbal product could be a cosmetic, an ayurvedic medicine, a drug, a food or food supplement (neutraceutical ) , or a food additive. It is necessary to appreciate that regulations are not based on the herbal material per se, but on the intended use of the material.
Herbal cosmetics are formulated using permissible cosmetic ingredients to form as base in which one or more herbals or herbal ingredients are used to provide defined cosmetic benefits. The label must declare it as Herbal Cosmetic. The license is obtained from the state’s FDA under the Drugs and Cosmetic Act and Rules. There should be compliance with the GMP requirements for cosmetics manufacture. There are issues regarding whether a product is a drug or cosmetic, since at times the ingredients are mentioned as drugs in the authentic texts. A schedule has been introduced under the Drugs and Cosmetics Act mentioning ingredients and recommended for oral, skin, hair and body care in saundarya prasadak — husne afza.
An ayurvedic medicine is manufactured as per recipe or formulation listed in the Books of First Schedule of Drugs and Cosmetics Act, and the method of manufacturing / processing is as per the book. It is made under Ayurved Drug License. There is a provision for proprietory, Ayurvedic Medicine License for drugs which have one or more ingredients / herb mentioned in any one of the book referred above. These are classical / grantha Ayurvedic drugs. There are no provisions for New Ayurvedic Drugs / Medicines, and no provisions for the import of Ayurvedic drugs / medicines. The law is silent on these areas. Though there are manufacturing licenses required for Ayurvedic Medicines, there is no need for sale licenses for outlets that stock, distribute and sell Ayurvedic medicines.
A herbal product becomes a drug where drug’s definition under the Act can be applied to it. These products are approved if they satisfy the standards of purity and potency given in the official book or pharmacopeia. There were monographs for herbs / herbal products years ago in the I.P. However, in the last two decades, these have been deleted. More presence of the monograph does not mean they are drugs but these must be approved under Drugs Rules 122 from C DSCO and DCGI as a new drug. There is no bar for a herbal to apply for approval as a drug but the requirements here are tilted in favour of synthetic molecules. To overcome this, a definition of phytopharmaceuticals has been introduced. There are scientific studies on quality, system and efficacy on lines equal to a drug, but these are to be Gazetted yet. There are still many herbal products marketed as drugs on the basis licenses issued long time ago.
The Food safety Standards Act and Rules ( FSSA and FSSR ) govern herbal products as food or food supplement. Under the Act, food means any substance which is intended for human consumption. It could be processed or unprocessed. It includes primary food, genetically modified or engineered food, food containing such ingredients, infant food, packaged drinking water, alchoholic drink, chewing gum and any substance ( including water ) used into the food during its manufacture, preparation or treatment. It does not include any animal feed, live animals unless they are prepared or processed for placing on the market for human consumption, plants prior to harvesting, drugs and medicinal products, cosmetics, narcotic or psychotropic substances. Any other article can be declared as food by the Government. A food additive is only substance not normally consumed as food by itself or used as a typical ingredient of the food but is added intentionally to food for a technological purpose affecting the characteristics of such food.
There are 370 foods defined under the Act and standards are spelled out for them. Foods for which no standards have been specified can be manufactured and marketed as proprietary food.
It is proposed to market Ayurvedic, Siddha, Unani ingredients known for their history as supplements. Herbal products marketed is food must meet the labeling requirements. There is no bar on herbs being added to food even if they are not known in India provided adequate data about its efficacy, quality and safety are available. Some of these can be classified as Novel Foods. Foods should not make clinical claims. The Export regulations are yet to be streamlined.
Herbal food additives merit attention. Food additives are gums, starches, oleo resins, food colours, distilled oils.
Herbal products for veterinary use should also be studied.
Herbal extracts ( standardised extracts ) are used. But the concept of active pharmaceutical ingredients does not exist in Ayurvedic drugs or foods. Thus manufacture of such extracts faces many problems.