Re: Quality of medicines - FDA approval labels

[Guest guest]

Dear AllThis may sound too naive but the fact is that most prescribers and pharmacist would not know how to assess the quality of medicine. The prescriber will learn through experience, AFTER the patine has consumed the medicine and has not responded or has developed some problems. Are the two professionals frromally trained to recognise GOOD QUALITY medicines. I am not sure about pharmacists, but prescribers are certainly not trained. In such a scenario, it is quite " natural " or " practical " for them to believe what the MRs tell them or to go by hearsay or " GUT FEELING " ...all of which can be misleading! Any tips on this point??

Chetna2008/11/2 Dr. Keshetti Srisailam <ksrisailam@...>

Dear Members

The maintenance of quality medicines is the prime responsibility of the professionals like us, i.e., physicians and pharmacists mainly. This is because of the fact that the patient does not know anything about the quality. When a consumer visits a provisions store, he has the choice to buy the product of his interest basing on his previous experience or faith on a company. Sometimes the marks like ISI, Agmark etc. will help the consumer to buy a quality product required for his daily life. When it comes to medicine, the situation will be different. There wont be any choice to the patient to buy a good quality medicine. He will buy the medicine prescribed by the physician and dispensed by a pharmacist. Hence the role of physician is much more important in prescribing medicines of good quality. Of course, the pharmacist should also take care about the quality of the product he dispenses. Because he is the person responsible to take care of proper

storage, expiry dates etc.

Now a days many pharmaceutical units are getting approved by FDA and maintaining quality in respect to the manufacturing facilities and thus products. I strongly request the learned members to suggest drug regulatory authorities to make it mandatory that few words like " This product was manufactured in FDA approved manufacturing unit " should be printed on the label of a medicine. This will definitely help the patient to know something about the quality of medicine that he buys.

With regards

Dr. Srisailam K

Contact: Office: Dr. Srisailam Keshetti, Associate Professor, Vaagdevi College of Pharmacy, Ramnagar, Hanamkonda, Warangal - 506001, AP, INDIA, Ph. +91 870 2455111(O), Fax +91 870 2460108. Residence: Dr. Srisailam Keshetti, H.No. 5-11-531, Naimnagar, Hanamkonda, Warangal - 506009, AP, India, Ph. +91 98493 05115, +91 92468 94465 Alternate email id: ksrisailam@... Permanent Address: Dr. Srisailam Keshetti, H.No. 2-10-2095, Bhagya Nagar, Karimnagar - 505001, AP, India. Ph: +91 878 6504465

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-- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016Visit http://www.pharmacologybjmc.org

http://pharmacbjmc.110mb.comwww.poliofoundation.org

[Guest guest]

Dear Dr.Srisailam,What Vijay says is true to an extent. But how will the FDA know that a product is in the market if it has been manufactured without a licence?Just putting a label FDA approved will not solve the problem because companies will do anything to circumvent rules including printing that without approval.

To give you an example - my personal experience:We had ordered succinyl choline from one of the " good " companies. The stock arrived without cold chain maintainence. We rejected it and as per our tender conditions returned the stock asking for a fresh stock with cold chain. Just before returning the stock, I took six boxes and placed a tick mark over the boxes and on the labels of the vials with a red marker. I did not tell this to anyone.

After two weeks we received " fresh " stock with good cold chain maintenence. When the supplies were opened - lo and behold I found all six boxes with vials intact. The company claims it was a " mistake " and a new employee probably did it. All this after allowing me to fret and fume for months - knowing fully well that with time the initial anger, irritation would have died down.

This is why I am scared that when we return any stock, it will simply be dressed up in fresh labels and packaging and sold off to the unsuspecting hospital.About two months back a similar incident happened with an RIA kit which I had procured at the cost of Rs.36,000/= per 100 tests for a research project. The kit arrived warm to touch. I returned it again after placing some crosses with a red ballpoint pen on the bottles of standards inside the kit. After three weeks I received the same kit with good cold chain. The company had the audacity to say " madam please do the tests and see - if it is not working we will replace it free of cost " . I complained to the parent company in Germany who wrote polite letters. I tried to publish this incident as a letter to editor - no journal in India is interested.

This is the extent to which companies will go - to cheat the consumers.Good news is that the drug committee blacklisted that company from supplying medicines to jipmer.Gitanjali

On Sun, Nov 2, 2008 at 4:23 PM, Dr. Keshetti Srisailam <ksrisailam@...> wrote:

Dear Members

The maintenance of quality medicines is the prime responsibility of the professionals like us, i.e., physicians and pharmacists mainly. This is because of the fact that the patient does not know anything about the quality. When a consumer visits a provisions store, he has the choice to buy the product of his interest basing on his previous experience or faith on a company. Sometimes the marks like ISI, Agmark etc. will help the consumer to buy a quality product required for his daily life. When it comes to medicine, the situation will be different. There wont be any choice to the patient to buy a good quality medicine. He will buy the medicine prescribed by the physician and dispensed by a pharmacist. Hence the role of physician is much more important in prescribing medicines of good quality. Of course, the pharmacist should also take care about the quality of the product he dispenses. Because he is the person responsible to take care of proper

storage, expiry dates etc.

Now a days many pharmaceutical units are getting approved by FDA and maintaining quality in respect to the manufacturing facilities and thus products. I strongly request the learned members to suggest drug regulatory authorities to make it mandatory that few words like " This product was manufactured in FDA approved manufacturing unit " should be printed on the label of a medicine. This will definitely help the patient to know something about the quality of medicine that he buys.

With regards

Dr. Srisailam K

Contact: Office: Dr. Srisailam Keshetti, Associate Professor, Vaagdevi College of Pharmacy, Ramnagar, Hanamkonda, Warangal - 506001, AP, INDIA, Ph. +91 870 2455111(O), Fax +91 870 2460108. Residence: Dr. Srisailam Keshetti, H.No. 5-11-531, Naimnagar, Hanamkonda, Warangal - 506009, AP, India, Ph. +91 98493 05115, +91 92468 94465 Alternate email id: ksrisailam@... Permanent Address: Dr. Srisailam Keshetti, H.No. 2-10-2095, Bhagya Nagar, Karimnagar - 505001, AP, India. Ph: +91 878 6504465

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-- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & Research

Pondicherry 605 006India

[Guest guest]

Dear Dr. Gitanjali

I strongly support your comment that companies will do anything to circumvent rules.

But now a days so many companies are going for FDA approval and getting approved their manufacturing units.

Being a researcher in pharmaceutical field, I know most of the production units of reputed companies are FDA approved.

I am not saying that their products are upto the quality, but I can say that FDA approval process is not an easy one and a company should meet lot of stringent guidelines, regulations and quality aspects in their production units in order to obtain FDA approval.

But to my knowledge, FDA approved units manufacture atleast some higher quality medicines. So we can expect somewhat better quality medicines from such units. Like a bird in the hand is two in the bush, atleast we can assure better quality when the units are FDA approved.

I also agree with your bitter experiences with two products you mentioned.

Being associated with few pharmacies for the past twenty years, I too have observed some gimmicks played by the companies.

Many times we have returned the near expiry stock to the dealer and asked to forward the same to the company. I dont know exactly what the company did with that stock. But sometimes we receive products on which a small sticker will be pasted to cover the old information like batch number, manufacturing date and expiry date. I dont know exactly what has happened in the process. Why the company pasted a new sticker? Whether the old medication in the bottle or strip is replaced? or the same old stock was masked with new batch number, mfg date and expiry dates? When the old preparation is replaced in the bottle, cant the company afford the cost of a new label? Above all these, why should the company use old bottles/strips and old labels? This is one more gimmick some companies play.

I am sad to know that no journal in India come forward to publish your finding. Establishment of own laboratories and publishing own magazines and journals may solve these problems. But even after that how many organisations face the consequences in India. We all know the story of pesticide residues in soft drinks that was studied and published by Center for Science and Ennvironment (CSE), New Delhi and the consequences they faced after publishing the results.

Dr. Srisailam K

Dear MembersThe maintenance of quality medicines is the prime responsibility of the professionals like us, i.e., physicians and pharmacists mainly. This is because of the fact that the patient does not know anything about the quality. When a consumer visits a provisions store, he has the choice to buy the product of his interest basing on his previous experience or faith on a company. Sometimes the marks like ISI, Agmark etc. will help the consumer to buy a quality product required for his daily life. When it comes to medicine, the situation will be different. There wont be any choice to the patient to buy a good quality medicine. He will buy the medicine prescribed by the physician and dispensed by a pharmacist. Hence the role of physician is much more important in prescribing medicines of good quality. Of course, the pharmacist should also take care about the quality of the product he dispenses. Because he is the person responsible to take

care of properstorage, expiry dates etc.Now a days many pharmaceutical units are getting approved by FDA and maintaining quality in respect to the manufacturing facilities and thus products. I strongly request the learned members to suggest drug regulatory authorities to make it mandatory that few words like "This product was manufactured in FDA approved manufacturing unit" should be printed on the label of a medicine. This will definitely help the patient to know something about the quality of medicine that he buys.With regards Dr. Srisailam KContact: Office: Dr. Srisailam Keshetti, Associate Professor, Vaagdevi College of Pharmacy, Ramnagar, Hanamkonda, Warangal - 506001, AP, INDIA, Ph. +91 870 2455111(O), Fax +91 870 2460108. Residence: Dr. Srisailam Keshetti, H.No. 5-11-531, Naimnagar, Hanamkonda, Warangal - 506009, AP, India, Ph. +91 98493 05115, +91 92468 94465 Alternate email id: ksrisailam@rediffma il.com Permanent Address: Dr. Srisailam Keshetti, H.No. 2-10-2095, Bhagya Nagar, Karimnagar - 505001, AP, India. Ph: +91 878 6504465New Email addresses available on Get the Email name you & #39;ve always wanted on the new @ymail and @rocketmail. Hurry before someone else does!http://mail. promotions. / newdomains/ aa/-- Dr.Gitanjali Batmanabane MD PhDProfessor of Pharmacology & Officer-in-charge,Dept. of PharmacyJawaharlal Institute of Postgraduate Medical Education & ResearchPondicherry 605 006India

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[Guest guest]

Bravo Gitanjali for the exposition.

Vijay

>

> > Dear Members

> >

> > The maintenance of quality medicines is the prime responsibility

of the

> > professionals like us, i.e., physicians and pharmacists mainly.

This is

> > because of the fact that the patient does not know anything

about the

> > quality. When a consumer visits a provisions store, he has the

choice to buy

> > the product of his interest basing on his previous experience or

faith on a

> > company. Sometimes the marks like ISI, Agmark etc. will help the

consumer to

> > buy a quality product required for his daily life. When it comes

to

> > medicine, the situation will be different. There wont be any

choice to the

> > patient to buy a good quality medicine. He will buy the medicine

prescribed

> > by the physician and dispensed by a pharmacist. Hence the role

of physician

> > is much more important in prescribing medicines of good quality.

Of course,

> > the pharmacist should also take care about the quality of the

product he

> > dispenses. Because he is the person responsible to take care of

proper

> > storage, expiry dates etc.

> >

> > Now a days many pharmaceutical units are getting approved by FDA

and

> > maintaining quality in respect to the manufacturing facilities

and thus

> > products. I strongly request the learned members to suggest drug

regulatory

> > authorities to make it mandatory that few words like " This

product was

> > manufactured in FDA approved manufacturing unit " should be

printed on the

> > label of a medicine. This will definitely help the patient to

know something

> > about the quality of medicine that he buys.

> >

> > With regards

> >

> > Dr. Srisailam K

> >

> > Contact: Office: Dr. Srisailam Keshetti, Associate Professor,

Vaagdevi

> > College of Pharmacy, Ramnagar, Hanamkonda, Warangal - 506001,

AP, INDIA, Ph.

> > +91 870 2455111(O), Fax +91 870 2460108. Residence: Dr.

Srisailam Keshetti,

> > H.No. 5-11-531, Naimnagar, Hanamkonda, Warangal - 506009, AP,

India, Ph.

> > +91 98493 05115, +91 92468 94465 Alternate email id:

> > ksrisailam@... <ksrisailam%40rediffmail.com> Permanent

> > Address: Dr. Srisailam Keshetti, H.No. 2-10-2095, Bhagya Nagar,

Karimnagar -

> > 505001, AP, India. Ph: +91 878 6504465

> >

> > New Email addresses available on

> > Get the Email name you & #39;ve always wanted on the new @ymail and

> > @rocketmail.

> > Hurry before someone else does!

> > http://mail.promotions./newdomains/aa/

> >

> >

>

>

>

> --

> Dr.Gitanjali Batmanabane MD PhD

> Professor of Pharmacology & Officer-in-charge,

> Dept. of Pharmacy

> Jawaharlal Institute of Postgraduate Medical Education & Research

> Pondicherry 605 006

> India

>