Schedule H1 in Drug And Cosmetics Act of India

The Government Of India on a wide notification No. dated Aug. 30 2013 vide GSR (588) 3 has amended the Drug And Cosmetics Act  to include new Schedule, namely Schedule H1.
Please fine below here certain salient feature of the same :

• the schedule H1 will be in effect from March 1, 2014.
• Schedule H1 consists of a list of 46 drugs, which is given in annexure 1
• Those retailers who are doing manual billing ( not computerized ) are advised to keep separate bill books  or separate series of bill numbers, so that they can produce the records immediately when asked by the drug control officials.
• Those retailers using computerized billing are advised to fill the column of schedule in the product master  against those drugs included in the Schedule H1 , as Schedule H1.
• Retailers have to maintain a separate register to record the sale of Schedule H1 drugs.TheSchedule H1 register should have the following columns :
• Name of the product and potency
• Quantity sold
• Name and Address of the prescriber
• Name and Address of the patient
• These records are to be maintained for a period of minimum three (3) years.
• It is mandatory from March 1, 2014 that all the products included in schedule H1 are labelled with Schedule H1 warning " To be sold by retail only on the prescription of a Registered Medical Practitioner only" in a box with red border.
• Preparation of the Schedule H1 drugs containing products for topical and external use are not included in the schedule.
• Facts in the Law which automatically apply to the Schedule H1 :
• These drugs are to be sold only against the prescription of a Registered Medical Practitioner .
• The prescription has to be complete in all aspects with all details.
• When the prescription mis dispensed, the pharmacy/ medical store has to put the dispensed/ supplied stamp, date and sign on it .
• A prescription can be dispensed only once unless the doctor specifies in writing that it can be dispensed more than once, and how many times.
• verbals, telephonic, E- mail, Fax, SMS etc. requests / orders for dispensing Schedule H1 Cannot Be entertained.

ANNEXURE 1 :

Alprazolam, Balofloxacin, buprenorphine, capreomycin, cefdinir, cefditoren, cefepime,cefetamet, cefixime, cefoperazone, cefotaxime, cefpirome, cefpodoxime, ceftazidime, cefibuten, ceftriaxone, ceftizoxime, chlordiazepoxide, clofazimine, codeine, cycloserin, diazepam, diphenoxylate, doripenem, ertapenem, ethambutol hydrochloride, ethionamide, feropenem, gemifloxacin, imipenem, isoniazid, lecofloxacin, meropenem, midazolam, moxifloxacin, nitrazepam, pentazocine, prulifloxacin, pyrizinamide, rifabutin, rifampicin, sodium para aminosalicylate, sparfloxacin, thiacetazone, tramadol, zolpidem.

NOTE : In case of any query about schedule H1, please consult the drug inspector of your area in FDA Office. 

Latest DPCO list of 614 drugs with review

Latest molecules added in DPCO List are attached.
In total 614 drugs have been included under DPCO list.
The FDA is releasing prices of drugs step by step.The prices of all products are yet to be released by government.

Flaws in DPCO :

Strengths given in the list only covered under list.
For.  ex. paracetamol Tab. is under the act but paracetamol infusion is not.

Combinations are not covered under DPCO List.
For. Ex. Azithromycin is covered under Dpco
              Ofloxacin is also covered under DPCO
              but Azithromycin and Ofloxacin Combination is not under DPCO
hence drug manufacturers get a great place to run away from law.

Cluster Pharmacy - New ray of hope

History :

             Thanks to Mahesh Zagade, FDA Commissioner of Maharashtra and Aamir Khan's Satyamev Jayate or What exactly i dont know, but after episodes of Female Foeticide and Generic Medicines FDA revamped like anything.Since late December 2012 they started raiding medical stores in Maharashtra ensuring availability of Pharmacists in every medical . Around more than 100 medical store owners were sent notices because of non presence of registered Pharmacist during sale of medicine.
This was going on in  whole Maharashtra
See link of Pune Zone..
.http://articles.timesofindia.indiatimes.com/2013-01-28/pune/36595990_1_medical-stores-drugs-of-various-schedules-expiry-date

This action of FDI sent strong message in Non Pharmacist medical store owners about compliance of The Pharmacy Act.
And indirectly there was a steep rise in demand of registered Pharmacists.
Earlier Career option for Pharmacists were :
Manufacturing
Marketing
Medical Stores

People who did not open medical stores offered their Pharmacist Registration to Non Pharmacy owners for a mere amount ranging from 700 to 3000 per month depending upon city. But this action has stopped this extra income of pharmacists.

Current Scenario :

             Whenever asked for going to garden with wife, going to school on parents day of your son/ Daughter, going to marriage of friends, visitng a relative in hospital,
the answer of a owner pharmacist is fixed and is Sorry yaar i desperately want to come with you, but i cant...! 
Reliever nahi hey !!  Problem ho jayega.., etc etc reasons are normally given by Pharmacists Owner of Medical Store Owners due to Legal bindings on them.
All you can say is Sunday hey toh jaroor aaunga !

Since the inspection of Drug Inspectors in Maharastra has seen rise many medical store owner pharmacists are under pressure as how to manage balance between personal and professional life as Pharma Laws demand availability of a Registered Pharmacist all time in the medical store whenever it is open.
 May it be a Road side medical store or Hospital attached medical store they are much affected of this legal binding. And a medical store may not always afford to pay a Extra Pharmacist.

So in Such cases 'Cluster Pharmacy " project may prove to be a boon....!!

What is it??

               A group Minimum 10 and maximum 15 of medical store owners in same area come together to form a cluster. They should be located in same zone of FDA and should come in zone/ area of single Drug Inspector is the only important condition !!
They appoint a pharmacist for them all together.This will be informed in writing to local FDA branch. On approval he now is the official reliever of the cluster members.

In case any one of the group member has to go out of town for some days or he needs rest for few hours or he suddenly fells ill, all he has to do is inform local FDA in advance about it and our Cluster Pharmacist will be present in the stores for dispensing in the mean time.

Issues in implementing :
           Many issues are needed to be tackled as this concept is new and may need refurnishing, But this idea can be adopted after working a bit on it.Some issues i thought are solved here as per my ability.
Solutions from readers side are always welcome.

• Reneumeration to be paid... How will it be? on per hour basis or salary?

It could be done by paying on per hour basis by the store owner or fixed day pay.

• It is not a full time career option..?

Yes, it may be regarded as Part Time job but for housewives this is ideal job.
For Pharmacist who are more inclined to job security this might not be a good option but those who are having time and need to earn can always have this option.This option will also offer you tremendous knowledge and experience.

• Is this real? Never heard of such concept of licensed reliever in Indian pharma Retail Industry till today.

This is just a proposed concept. The Chemist Association or The Pharmacist Welfare Association or other relevant bodies may have to take it forth to the FDA as this is need of hour.

• People will say that Full time nahi mil raha Part- Time Pharmacist kaha milega?

This idea is more useful for owner Pharmacist people and not Non-pharmacist medical store owners.

Owner Pharmacist really miss the chord of family life due to their professional life as they have no holiday other than weekly off.
Case of Non Pharmacist Owner is different as they are not bound to be present in stores round the clock.

After working and discussing with more experienced people in the field this idea might work wonders.
Rounds of Serious debates need to happen on this concept so that it gets more clear, viable and applicable.

How can Pharmacists raise STANDARD OF PHARMACY:

Please do not offer your pharmacists registration license to any one at such a cheap rate. Consult with seniors about rates in your city.Not below 12000/- in Metro city at worst and 8000/- Tier I / II cities.

If you know any person who has offered already ask him to withdraw it immediately as it may be suspended or withheld by MSPC once found not present during sales in the medical stores.

Others are requested to inform local FDA office by writing in case you come across any medical stores where medicines are dispensed by a non-pharmacists.

I guess colleges must have debates to nurture Hospital pharmacists or community pharmacist as career option by giving them exposure as they are to getting well paid.

A pharmacist has to keep in mind various brands, substitutes, MRP's and availability in his stores. Its a highly challenging job. In fact many softwares are available to help in above case [duties various brands, substitutes, MRP's and availability in the stores]

Around 18180 Students pass out every year in Mahrashtra alone. [total  123 B.pharm Colleges, 180- D.Pharm colleges] Considering 20 % fail in final year, figure moves down to 16000 roughly. And vacancies remaining same, so it might be tough to secure jobs for everyone.

So ill be focusing on careers after Pharmacy in my next blog.