PHARMACOVIGILANCE for ASU& H Drugs: Present scenario and Future prospects.

Siddha By Dr.D.Kayalvizhi

Siddha medicines are safe, on contrary to majority of scientific articles on AS&U drugs stating that the “Safe” is either a misnomer or misconception. Provided that there is no mistake in manufacture, dispensing, prescribing or way of consumption. 

Medicines were earlier prepared by the physicians, right from picking the herb themselves to grinding, and processing. They were aware of the poisonous herbs, minerals and heavy metals along with proper purification techniques.

The global market for Indian system of medicine is expected to triple from 3.4 billion dollar in 2015 to 9.7 billion dollars in 2022. This is expected to grow larger in future considering the contribution in combating COVID-19 pandemic by providing possible therapeutic drugs, prophylactics and lifestyle modification advices. This recognition comes along with a great degree of scrutiny on the safety of Siddha medicines. 

Any system of medicine becomes obsolete if it denies growing parallel with the scientific advancements. but it shouldn’t be at the price of patient’s safety. Pharmacovigilance  plays a pivotal role in detection, assessment, understanding and prevention of adverse drug effects or any other possible drug-related problems.

Pharmacovigilance took the centre stage globally in the wake of Thalidomide disaster of 1961. WHO’s programme for International Drug monitoring began in 1968, with Uppsala Monitoring centre in Sweden as the collaborating. WHO became instrumental in proposing a formal drug safety monitoring system for the first time in India in 1986.Department of AYUSH, Ministry of Health and Family welfare, Government of India, launched the National Pharmacovigilance Program for reporting the adverse drug reaction for Ayurveda, Siddha and Unani drugs        ( NPP-ASU). Consequently in 2017-2018 , Central Sector scheme for promoting AS&U drugs was introduced by the Ministry of AYUSH with a three tier network i.e., National Pharmacovigilance Center( NPC ), Intermediary Pharmacovigilance Centre( IPC) and Peripheral Pharmacovigilance Centre( PPC). NPC status is designated to All India Institute of Ayurveda , 5 national institutes of AYUSH have been designated as the IPC and 42 AYUSH institutes with clinical facilities is allotted PPC satutus. Among which, 10 PPCs are allotted to Siddha drugs.Indian Pharmacoepia commission, beimg the WHO collaborating centre for pharmacovigilance in our country and representative from Central Drug Standards Control organization(CDSCO) being the national drug regulatory authority; are associated with this initiative as mentor and guide. This organized system helps in reporting any possible adverse effect enumerated by the physician and arrive at a causal relation. 

Where could the otherwise safe drugs become unsafe is influenced by the following features commonly grouped into 2- a) Raw drugs - Manufacturing

            b) Physician- Patients

Raw drugs - Manufacturing

India is a country with rich biodiversity, thereby generating complexities majorly in 2 arenas. Firstly, variation in pharmacological property or functional component in the same species of different origin. Ashwagantha procured from Rajasthan contains highest Withaferine A and WithanineB compared to other varieties found in India leading to bulk dispensing. Secondly, species identification i.e., conflicts pertaining with similarity of names of different herbs mentioned in classic literatures.For example: Semmuli used in Kabhasura kudineer.Proper storage and labelling of shelf life is important as hygroscopic drugs such as Chooranam and Ilagam, which are susceptible to fungal contaminations. Surveys in markets reveal herbs are being adultered or substituted. Sometimes due to the ambiguity in the names provided in classical texts and sometimes due to the unavailability of the required herb. Ashoka(Saraca indica) is a vulnerable tree and it is substituted with   Nethi lingam( Polyalthialongifolia)  and Cassia obovata with cassia senna leaves. Informal sector manufacturing of AS&U drugs on small scale is large and this often makes it impossible to identify the medicine that maybe causing the adverse reaction. 


The physician should have a sound knowledge about the patients Thega Ilakanam, Ennvagaithervu, NoiNilai according to which medicines should be prescribed along with proper understanding of ingredients present in the formulations. Time of Drug administration, Adjuvant and diet modification is mandate for proper, effective and specific action on target site. Prescribing medicines not compatible with the body type of the patient is important factor that results in adverse reactions. Some of us fail to adhere to duration of the drug and certain patients continue to use the medicine for their benefits for a prolonged period without consulting the physician. Ayurveda studies suggest that  Kanchnargugglu and Punarnava mandoor have induced liver injury on prolonged use. Siddhars have not indicated drugs for chronic use as opposed to how drugs are prescribed now irrespective of patients physiological state. Athimathuram(Glycyrrhizaglabra ) indicated for Sore throat and cough, when used ‘ non judiciously ‘ may cause hypokalaemic nephropathy, amenorrhoea hypertension and heart failure. Patients with non communicable disease tend to consume drugs from multiple systems of medicine. Concomitant use of Siddha medicines with modern medicines could lead to interactions altering the pharmacological effect of both the drugs. Studies suggest that interactions may occur at the level of biotransformation pathways of drugs which results in serum drug concentration or drug levels at the site of action.



It is a modern concept of monitoring the safety of medical devices. Siddha literatures have documents of several medicine preparation devices and therapy devices.Medicine preparing devices include Kalvam( A kind of mortar) , if made in Black stone gives medicine of highest potency. If it’s made with white or yellow stones- sub standard drugs may be produced. Similarly, for pounding purpose in general Iron Ulakkai is used. Certain medicine preparation procedures specifies the use of Poon illa ulakkai since there is a possiblilty for drug interacting with the iron . Thermal cautery, most commonly used for pain management and wart treatment  has a possibility of causing infection in case of open wound and depth of destruction may become difficult to control. Karanool therapy is a safe and effective treatment if done carefully under guidance, in case of procedural error may lead to post surgery complications, recurrence, bleeding, pain and infection. Hence materiovigilance can play a key role to analyze, scrutinize and prevent recurrence of harmful effects due to the use of medical devices.


  • Siddha pharmacovigilance  must be included in UG curriculum as they enter into clinical set up
  • Regular sensitization programs as CME or Workshops to quickly enumerate adverse reactions from pathological states and artful reporting in the individual case safety reports (ICSRs)
  • Launching speciality degree named Siddha Pharmacovigilance for Gunapadam post graduates to train in causal relationships and utilizing them in all hospital set up in order to  quickly report to peripheral pharmacovigilance centres.
  • Standard operating procedures need to be established for each and every step involved in medicine preparation, starting from raw drug procurement till the finished product is obtained.
  • Encouraging more clinical studies on Herb Drug interactions.
  • Adherence to Good manufacture practice(GMP), Good Agricultural practice (GAP)and Good Agricultural Collection Practice(GACP) for sustainable cultivation of medicinal plants as suggested by WHO.








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