88. Pharmacovigilance program in India - A brief review

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Another biggest blunder has been committed by our pharmacists in regulatory sector with their poor or ill understood knowledge on the therapeutics and the issues thereon. [The earlier blunder was starting of pharmacy courses within 4 walls away from hospital and community environment with useless and baseless subjects and topics with no relevance to the field reality]

Here are my genuine concern on the pharmacovigilance program:

Weakness in the current pharmacovigilance program:

It has been started on a wrong note considering the export volume and potential instead of feasibility study and instances and magnitude of incidences of ADRs as could be seen in the proposal document submitted by the CDSCO to the Govt of India.

CDSCO cannot be an agency to start pharmacovigilance program as:

  1. ADR is not an offense under D&C Act and Rules.
  2. ADR monitoring is not a policing system
  3. CDSCO does not have the required clinical background or experience to understand the concept of Pharmacovigilance and ADRs
  4. CDSCO has proposed Pharmacovigilance program based not on the feasibility and need analysis but on the basis of the export volumed and potential, a clear indication that CDSCO do not know the subject matter at all.
  5. The committees and staff structures proposed in the policy / structure document is irrelevant and inconsistent.

Well, how it should done :

  1. Pharmacovigilance and ADR analysis is a clinical pharmacy subject and is a part and parcel of Clinical activity under Healthcare system.
  2. It should be managed by professionals who are familiar with both clinical and pharma knowledge Viz: Clinical pharmacists under Pharmacare program.
  3. Pharmaco-vigilance should be established under hospital based 'Pharmacare' program.
  4. Pharmacare program includes logistical pharmacy and Clinical pharmacy.
  5. Pharmacare department should be established in all the hospitals with 100 beds and above.
  6. There should be a network of Pharmacy Therapeutic committee with National, Zonal, State level and Hospital level therapeutic committee with a pharmacist as its member secretary.
  7. Pharmacovigilance program should involve the doctors, nurses and pharmacists in its activities.
  8. There should be an open channel for the doctors, nurses and patient / his attendant to report the AD events.
  9. The Pharmacovigilance and ADR analysis cannot happen effectively without a good network of Pharmacy Therapeutic Committee.
  10. Only the Pharmacy Therapeutic Committee can discuss and analyze the data and make recommendations
  11. The Pharmacy Therapeutic committee will get enriched with abundant data from the Pharmacare department and pharmacovigilance activity to promote competently the National Medication Policy.
    1. Pharmacy Therapeutic committee should remain as guardian for safe and effective medication.
    2. Therapeutic committee shall not involve collectively in any way in tender, tender evaluation and procurement process except in preparation of Essential Drugs List with specification for tender.

About the Author

Ph. Bhagavan P S RPh's picture

I am Bhagavan ,Rtd. Dy Dir.(Pharmacy),Govt of Karnataka, India and currently serving as Registrar, KSPC, Bengaluru, India . I love to write on Hospital pharmacy series related topics out of my experience and observations. Check out my Pharmacist in the Hospital.


Prof. J. Vijaya Ratna's picture

Dear Sir

This blog again is a good attempt to put the spot light on the monitoring of ADRs and the changes required in the hospitals. A good Pharmacy and Therapeutics Committee can check the ADRs. If only hospital authorities are ready to employ highly qualified pharma people and give them proper role, then definitely there will be better pharmacare, and lesser ADRs. I feel that in our hospitals, doctors have the tendency to prescribe a lot more medicines than are actually needed. Example: Many patients come out of the pharmacy counter with a strip of 10 tablets of diclofenac, two strips of Ranitidine (20 tablets), and 30 tablets of Vitamin B complex. I advise all such patients I come across ' Use the diclofenac (twice a day) and the ranitidine (twice a day) only as long as you have pain. Stop them as soon as pain subsides. Some questions bother me. What happens to the patients who use all the diclofenac and ranitidine whether they need it or not? Or if they stop after two or three days, is it not a lot of waste, when the remainig tablets are wasted? What should be the ideal period for which medicines are to be given? I suppose a Pharmacy and therapeutics Committee would discuss such issues and take decisions.

I hope you don't mind my tendency to tell my own stories, in the midst of commenting on your article on policy issues and discussion of the situation at a macro level.

Anyway, one thing is for sure. The presence of a well educated pharmacist in a hospital would definitely help in better delivery of Pharmacare.

Vijaya Ratna

Ph. Bhagavan P S RPh's picture

Thank you madam.

Absolutely nothing wrong on your part to share your experience as it would be more a live example than literature based comment.

The prescriptions of the type you mentioned and incomplete prescriptions are rampant everywhere and I do not know why there is no regulatory measure for such irrational advice with absolutely no follow up.

Our Indian doctors though are very polite while examining the patient and handing out the prescription are invariably arrogant and egoistic and cannot bear any comment or questioning.

Just take what I have given.

Another question.. You are free to go to another doctor if you want. Dont question me on my prescription.

A gynecologist had prescribed a herbal tonic to my wife for a skin tag /tac !

A strong therapeutic committee and a standardized Prescription audit System (PaS) is the best answer.

One doctor bounced on me at the very mention of Prescription audit but latter cooled down when I explained that PaS is not a fault finding exercise but a system that gives scientific and professional feed-back. It generates a vast data of use-misuse-abuse of drugs. Further, the beauty of irrational prescription is: It is not a wrong prescription but a bad prescription. hence it cannot be considered as a Good prescription.

He got so so much confused with my explanation but enjoyed the joke part of it.

As regards the ADR , there is an obvious fear among clinicians to report ADR.

The fear is the apprehension that the report could be used agaisnt him / her . Hence, since Pharmacovigilance and ADR documentation and analysis etc are academic procedures to learn and to prevent recurrence as far as possible, the data should be guarded against such use.

As pharmacists we too have to understand the funstioning of therapeutic system. An action taken in a live scenario should not be attacked or challenged with literature knowledge.

Pharmacist is only a supporting staff. He should respect and support the doctor who is the leader of the therapeutic team..

Reckless, irrelevant and irrational questioning and commenting on a prescribed therapy is not only unprofessional but also not a healthy habit. Such attitude and habits not only stumps the growth of the Pharmacist but kills the profession.

Again Thank you madam,

Bhagavan P.S. B Pharm

Rtd. Dy Dir.(Pharmacy),Govt of Karnataka, India
Prof. J. Vijaya Ratna's picture

Dear Sir

This question is a result of a discussion I had with our clinical pharmacists. When a patient comes with a big strip of diclofenac tablets, may a pharmacist tell him/her that the painkiller may be stopped if and when the pain subsides? Or is it wrong on the part of the pharmacist to give that advice? My friends say that a pharmacist may give such an advice only when the doctor writes "SOS".

But, when the patient reports pain, when the doctors prescribes diclofenac for five days, suppose the pain goes down in one or two days, then is he not unnecessarily using diclofenac for three more days? Is it not unnecessary burden on his/her health system?

Vijaya Ratna

Ph. Bhagavan P S RPh's picture

Your observation is quite apt.

It is a tragedy that irrational prescription has become the order of the day..

As I have said elsewhere irrational prescription is only a bad prescription.

The explanation for irrational prescription could be that:

  1. It is a prescription with loaded molecules to attack every symptom expressed by the patient.
  2. Loading one molecule to counter the side effects of another molecule
  3. Poly-clinic's add-ons
  4. Shot-gun prescriptions - with a hope that at least one would act
  5. Apprehensive medications


I still remember the opening statement in my Pharmacology book that was popularly being called 'Three authors pharmacology':


Here, in this case the answer is both correct and incorrect:

It is correct, if the doctor has felt that such an analgesic, antipyretic and anti-inflammatory effect is needed for 5 days to allowthe body to recoup.

It is incorrect, if the issue could have been addressed with an SOS therapy.

That means as I have said else where, prescription originating from a live scenario cannot be directly questioned with literature data.

All that needs to be done is to seek clarification from the doctor.

  • Should he continue even if the pain subsides within a day or two?


  • Can he stop the medication if he stops feeling pain?


  • Should he be advised to continue even if the pain is not felt?

Bhagavan P.S. B Pharm

Rtd. Dy Dir.(Pharmacy),Govt of Karnataka, India

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