Renewal Omitted: No Need for Renewal of Pharmaceutical Drug Licences and its Effect

With effect from new amendment in Drug and Cosmetic Act, 1945, you will not need for renewal of your drug license in future. If you have Retail/Pharmacy, Wholesale/Distribution, Loan or Manufacturing License Form* for pharmaceutical and cosmetic preparations then you will have no need to renew it.

You only need to deposit license retention fee before expiring of a period of every succeeding five years from date of issue of its issue, unless it is suspended or cancelled by licensing authority.

In case Licencee failed to deposit this fees at due time, then licencee shall be liable to pay licence retention fee along with a late fee calculated at the rate of two percent. In case of of non payment till six month, License shall be deemed to have been cancelled.

This amendment will be beneficial for all pharma business correspondents. It was tricky process to renew drug license. One has to follow complete process as in case of new license.

Now this amendment will provide relief to all manufacturing, wholesale and retail licencee whose licence were due this year and in future.

But few rules also been added through this amendment. Now your premises will be inspected by drug inspector at compulsory basis for minimum of one time in three year. Maximum number of inspection could be as needed as per risked based approach.

More rule is added in the provision.

For Retail and Wholesale: – Inspection for verification of compliance:  “The licensing authority shall cause inspection, by the Inspector  appointed under the Act, of each premises licensed under this Part, to verify the compliance with the conditions of licence and the provisions of the Act and these rules, not less than once in three years or as needed as per risk based approach.”

For Manufacturing and Loan Licensing:-  Inspection for grant of licence and verification of compliance.-

“(1) Before a licence in Form —–* is granted, the licensing authority shall cause the establishment in which the manufacture of drugs is proposed to be conducted or being conducted to be inspected jointly by the Drugs Inspectors appointed by the Central Government and the State Government under this Act who shall examine the establishment intended to be used or being used for the manufacture of drugs.

(2) The premises licensed under sub-rule (1) shall be inspected jointly by Inspector appointed by the Central Government and State Government to verify the compliance with the conditions of licence and the provisions of the Act and these rules not less than once in three years or as needed as per risk based approach.”

Same rules will also be applicable for manufacturing and loan licensing of cosmetic and Homeopathy products.

Effect of omitting Renewal at Pharmaceutical Sector:

  1. Renewal was a time consuming process. This will prevent time consumed during this process.
  2. It will build transparency in drug license process.
  3. Work Overload of drug department will be less. Now Drug Department can concentrate at proper implementation of laws and rules according to Drug and Cosmetic Act.
  4. Inspection will be compulsory. It will forced licencee to fulfill all requirements as drug department may conduct inspection at regular basis.
  5.  This amendment is focus at implementing good manufacturing standards as new plants will be inspected by Joint team of Center and State Drug Authority.
  6. Quality of Products manufactured in India may improve as manufacturing standard compliance could be regularly checked.
  7. More control of Drug Authorities will be at ground level for maintaining standards and availability of quality products.

* Form:

Form 19, Form 19A, Form 19AA and Form 19C, Forms 20, 20A, 20B, 20BB, 21C, 21CC, 20F, 20G, 21, 21A, 21B or Form 21BB,  Form 24, Form 24A, Form 24B, Form 24C, Form 24F, Form 25 or Form 25A or Form 25B or Form 25F, Form 26, Form 26A, Form 26B, Form 26F, Form 26H, Form 27, Form 27A, Form 27B, Form 27D, Form 27DA, Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA, Form 31 and Form 31A, Form 32 or Form 32A, Form 33, Form 33, Form 33A, Form 37 and Form 38. Know more about form Read our Article: Types of Licences required to start business in Pharmaceutical Sector

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

How can a B. Pharm Student Start Small Scale Manufacturing Unit?

Query:I am a final year b.pharm student. I am willing to start a small scale manufacturing unit related to food or cosmetics but I don’t have a clear idea regarding it. Please help and suggest me in what areas i can startup my business in food or cosmetics and also how much time and money will all this process need.Waiting for your reply. Thank you.

Response:Starting own business without any prior experience is not a good idea. You should first take some experience in food or cosmetic industry before starting own manufacturing unit.There are lot of challenges and works that can’t be learn during education, you could only be acquired by industry exposer.

Money and time needed depend at your experience and knowledge. Few person start own business with negligible amount and few start with huge amount. So we will recommend to get some exposer of industry after your education and then go into business.
Read our related article: What should a pharma student do just after graduation? Job or Business!
Documents and procedure for Food Business read at our article: How to start Food supplement business?
For cosmetic industry requirement read our article: How to start Cosmetic Industry in India?
For Pharmaceutical Industry requirement read our article: How to start Pharmaceutical Company?

Hope above information is helpful to you….
For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Related Articles:

What would be the Trade Margin Under New Pharma Policy?

New Pharma Policy is hot issue in pharmaceutical sector now days. There are many rumours circulating in industry about new pharma policy. Some may be true and some may be false. Most concern rumours are Banning of Contract and Loan License manufacturing, Fixing of Trade margins and removing brand name from single salt preparations. In this article, we are going to discuss about trade margin fixation. If trade margin has fixed then what could be it. Here we are taking the reference of Draft National Pharmaceutical Policy, 2006. Trade margin is complex phenomena and has been the subject of intense debate from time to time. Everyone has own views in this matter. If government fix trade margin then there is maximum possibility, it would be as described below:


Fixation of Trade Margins in Pharmaceutical Sector:
In case Trade Margin is to fixed then the trade margins for different drugs would be:

Drugs under price control (DPCO):

For Both Branded and Generics Drugs
Wholesaler Margin: 8% 

Retailer Margin: 16%

For Other Drugs(Not under Price control):

For Branded and Branded generics

Wholesaler Margin: 10% 
Retailer Margin: 20 %.
For Generics 
Wholesaler Margin: 15% 
Retailer Margin: 35%

All margins would be calculated on the MRP of drug or trade rate.

Related Article: New Pharma Policy: Would Third Party/Contract Manufacturing be Banned?

What is Prescription? Types and Contents of Medical Prescription?

Prescription Definition:
Prescription is a written, printed or in any other form document by a Registered Medical Practitioner or any other licensed practitioners e.g. Dentist, Veterinarian, BAMS etc which directs or instruct to a Registered Pharmacist to compound and/or dispense a specific type and quantity of preparation or prefabricated drug to a Patient.Types of Prescription:

  • Prescription for Extemporaneous preparations
  • Prescription for Official preparations
  • Prescription for Patent preparations

Contents of the Prescription :

  • Prescribers office information: Name, qualification, address & Regn. No.
  • Patient information: Name & address, Age, Sex, Ref.No.
  • Date
  • Rx Symbol (Known as Superscription Part)
  • Medication Prescribed (Known as Inscription Part)
  • Dispensing directions to Pharmacist (Known as Subscription Part)
  • Directions for patient [to be placed on lable]
  • Refill, Special labeling and /or other instructions
  • Prescriber’s signature and licence (or) Drug Enforcement Agency (DEA) number as required.

Under Drug and Cosmetic Act, 1945, A Prescription should have following particulars:

“For the purposes of clause (9) a prescription shall

(a) be in writing and be signed by the person giving it with his usual signature and be dated by him;

(b) specify the name and address of the person for whose treatment it is given, or the name and address of the owner of the animal if the drug is meant for veterinary use;]

(c) indicate the total amount of the medicine to be supplied and the dose to be taken.”

Let discuss more about Types of Prescription. Content of the prescription is clearly defined and don’t require any further elaboration to under. but many readers will be confused about types of prescription.

1. Prescription for Extemporaneous preparations: Extemporaneous Preparations are the preparations who are compounded to fit the unique needs of a patient by process of mixing drugs or modifying the concentration of a drug from that of the original manufacturer by a Pharmacist. Prescription containing Extemporaneous preparation is known as Prescription of Extemporaneous preparations. This process involve risk for the safety of patient and medical professionals. So Practitioner and pharmacist should follow strict regulation while compounding and Dispensing these preparations. These preparations can only be compounded if appropriate drugs or dosage form not available.

2. Prescription for Official preparations: Prescription containing medicines which are available in market as ready made form and available for dispensing only, no requirement of compounding for theses preparations.

3. Prescription for Patent preparations: Preparations that are prescribed come under patent law. Patented preparations includes preparations that are distributed by a company having a patent on its manufacture.

How many years the Schedule H1 Medicines Record To Be Kept Stored

Query:
I have some queries
1. What are the details of a patient and doctors has to be noted and to be keep in record ?
If possible plz attache specimen sample
2. For How many years the Schedule H1 Medicines Record To Be Kept Stored?
3. Is only purchase bill of schedule h1 drugs is to be maintained/stored or the sale bill of their is also?

Response:

  • Name and address of prescriber with patients name, name of drug, quantity dispensed shall be maintained in a separate register.Check reference/specimen copy by clicking at link of Drug Authority website
  • Record should be kept for 3 years.
  • All sale and purchase record shall be maintained for 3 years

For detail analysis read our article: Schedule H1 drugs and how to maintain record?

Query: 
How to maintain the record of sale of h1 drugs in a hospital pharmacy where these drugs are sold to both in patient and out patient.

Response: 
Maintain a register having detail of doctor against whose prescription medicines are issued and all patients to whom medicines are issued. Record maintenance is compulsory. You can maintain different register for indoor and outdoor patients. Read in detail about Schedule H1 drugs by clicking here

For any query and suggestion, mail us at pharmafranchiseehelp@gmail.com

Schedule U: Manufacturing records

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z

Schedule U:
Schedule U describes the particulars to be shown in manufacturing record. Following details are included in Schedule U:

1. Particulars to be shown in Manufacturing Records:

  • Substances other than Parenteral Preparation in General
  • Parenteral Preparations
2. Records of Raw Materials
3. Particulars to be recorded in the Analytical Records
  • Tablet and Capsules
  • Parenteral Preparations
  • For other Drugs
  • Raw Materials
  • Container, Packing Material Etc 
Schedule U(I):
Schedule U(I) describes the particulars to be shown in the manufacturing record for cosmetics
For detail analysis refer drug and cosmetic act and rules

Schedule N: List of Minimum Equipment for the Efficient Running of Pharmacy

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z


Schedule N:

Schedule N Describes the Equipment for efficient running of a Pharmacy:

1. Entrance. – The front of a pharmacy shall bear an inscription “Pharmacy” in front.

2. Premises. – The premises of a pharmacy shall be separated from rooms for private use. The premises shall be well built, dry, well lit and ventilated and, of sufficient dimensions to allow the goods in stock, especially medicaments and poisons to be kept in a clearly visible and appropriate manner. The areas of the section to be used as dispensing department shall be not less than 6 square meters for one pharmacist working therein with additional 2 square meters for each additional pharmacist. The height of the premises shall be at least 2.5 meters.
The floor of the pharmacy shall be smooth and washable. The walls shall be plastered or tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices.
A pharmacy shall be provided with ample supply of good quality water.
The dispensing department shall be separated by a barrier to prevent the admission of the public.

3. Furniture and apparatus. – The furniture and apparatus of a pharmacy shall be adopted to the uses for which they are intended and correspond to the size and requirements of the establishment.
Drugs, chemicals, and medicaments shall be kept in a room appropriate to their properties and in such special containers as will prevent any deterioration of the contents or of contents of containers kept near them. Drawers, glasses and other containers used for keeping medicaments shall be of suitable size and capable of being closed tightly to prevent the entry of dust.
Every container shall bear a label of appropriate size, easily readable with names of medicaments as given in the Pharmacopoeias.
A pharmacy shall be provided with a dispensing bench, the top of which shall be covered with washable and impervious material like stainless steel, laminated or plastic, etc.
A pharmacy shall be provided with a cupboard with lock and key for the storage of poisons and shall be clearly marked with the work ‘POISON’ in red letters on a white background.
Containers of all concentrated solution shall bear special label or marked with the words “To be diluted”.
A Pharmacy shall be provided with the following minimum apparatus and books necessary for making of official preparations and prescriptions:-

Apparatus: –
Balance, dispensing, sensitivity 30 mg.
Balance, counter, capacity 3 Kgm., sensitivity 1 gm.
Beakers, lipped, assorted sizes.
Bottles, prescription, ungraduated assorted sizes.
Corks assorted sizes and tapers.
Cork, extracter.
Evaporating dishes, porcelain.
Filter paper.
Funnels, glass.
Litmas paper, blue and red.
Measure glasses cylindrical 10 ml, 25 ml, 100 ml and 500 ml.
Mortars and pestles, glass.
Mortars and pestles, wedgwood.
Ointment pots with bakelite or suitable caps.
Ointment slab, porcelain
Pipette graduated, 2 ml, 5 ml and 10 ml.
Ring, stand (retort) iron, complete with rings.
Rubber stamps and pad
Scissors
Spatulas, rubber or vulcanite
Spatulas, stainless steel.
Spirit lamp
Glass stirring rods.
Thermometer, 0oC to 200oC.
Tripod stand.
Watch glasses.
Water bath.
Water distillation still in case Eye drops and Eye lotions are prepared.
Weights, Metric, 1 mg. to 100 gm.
Wire Gauze.
Pill finisher, boxwood.
Pill Machine.
Pill Boxes.
Suppository mould.
Books :
The Indian Pharmacopoeia (Current Edition).
National Formulary of Indian (Current Edition).
The Drugs and Cosmetics Act, 1940.
The Drugs and Cosmetics Rules, 1945.
The Pharmacy Act, 1948.
The Dangerous Drugs Act, 1930.

4. General provisions. – A pharmacy shall be conducted under the continuous personal supervision of a Registered Pharmacist whose name shall be displayed conspicuously in the premises.
The Pharmacist shall always put on clean white overalls.
The premises and fittings of the pharmacy shall be properly kept and everything shall be in good order and clean.
All records and registers shall be maintained in accordance with the laws in force.
Any container taken from the poison cupboard shall be replaced therein immediately after use and the cupboard locked. The keys of the poison cupboard shall be kept in the personal custody of the responsible person.

Medicaments when supplied shall have labels conforming to the provisions of laws in force.

Note: – The above requirements are subject to modifications at the discretion of the licensing authority, if he is of opinion that having regard to the nature of drugs dispensed, compounded or prepared by the licensee. It is necessary to relax the above requirements or to impose additional requirements in the circumstances of a particular case. The decision of the licensing authority in that regard shall be final.

(For detail analysis refer drug and cosmetic act and rules)

Schedule M: Good Manufacturing Practice

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z

Schedule M:

Schedule M describes Good Manufacturing Practices and Requirements of Premises. 
Schedule M provides the insights to achieve the objectives listed in schedule, each licensee shall evolve appropriate methodology, system and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs.
Part 1: Describes Good Manufacturing Practices For Premises and Material

Part 1A: Describes the Specific requirement for manufacture of sterile products. Parenteral preparations (Small Volumn Injections and Large Volumn Parenterals) and Sterile Ophthalmic Preparations

Part 1B: Describes the Specific requirements for manufacture of oral solid forms (Capsule and Teblets)

Part 1C: Describes the Specific Requirements for Manufacture of Oral Liquids (Syrups, Elixirs, Emulsions and Suspensions)


Part 1D: Describes the Specific requirements for Manufacture of Topical Products i.e. External Preparations (Cream, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting Powders and Identical Products)
Part 1E: Describes the Specific requirements for manufacture of Metered Dose Inhalers (MDI)

Part 1F: Describes the Specific requirements of premises, plant and material for manufacture of Active Pharmaceutical Ingredients (Bulk Drugs)

Part 2: Describes the Requirements of Plant and Equipment

Schedule M-1:

Schedule M-1 describes the Good Manufacturing Practice requirements of factory premises for manufacture of Homoeopathic preparations:

Schedule M-2:

Schedule M-2 describes the requirements of factory premises for manufacture of cosmetics

Schedule M-3:

Schedule M-3 describes the requirements of factory premises for manufacture of medical devices

(For detail analysis refer drug and cosmetic act and rules)

Schedule K:Exempted Drugs, Conditions and extent of exemption

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z

Schedule K:
Schedule K describe the exempted drugs, conditions and extent of exemption from all the provisions of Chapter IV of the Act and the Rules thereunder subject to the conditions.
The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.

Exemption is provided only against fulfillment of conditions specified in Schedule. 

Few Exempted Drugs are as follow: 
  • Drugs Labelled as ‘Not for medicinal Use’ 
  • Quinine and other antimalarial drugs as per conditioned mention in Schedule
  • Drugs supplied by a registered medical practitioner to his own patient or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practitioner if it is specially prepared with reference to the condition and for the use of an individual patient provided the registered medical practitioner is not (a) keeping an open shop or (b) selling across the counter or (c) engaged in the importation, manufacture, distribution or sale of 
  • All the provisions of Chapter IV of the Act and the Rules made thereunder, subject to the conditions mention in schedule 
  • Drugs supplied by a hospital or dispensary maintained or supported by Government or local body as per conditions mentioned in schedule
  • Whole Human Blood I.P. and/or its components stored for transfusion by a First Referral Unit Community Health Centre, Primary Health Centre and Hospital as per conditions mentioned in schedule
  • Quinine Sulphate as per conditions mentioned in schedule
  • Magnesium Sulphate as per conditions mentioned in schedule
  • Some substances which are used both as articles of food as well as drugs as per conditions mentioned in schedule
  • Substances intended to be used for destruction of vermin or insects as per conditions mentioned in schedule
  • Mechanical and Chemical Contraceptives as per conditions mentioned in Schedule
  • Some household Asprin Tablets, Paracetamol Tablets, Analgesic Balms, Antacid Preparations, Gripe Water for use of infants, Inhalers, containing drugs for treatment of cold and nasal congestion, Syrups, lozenges, pills and tablets for cough, Liniments for external use, Skin ointments and ointments for burns, Absorbent cotton wool, bandages, absorbent gauze and adhesive
  • plaster, Castor Oil, liquid Paraffin and Epsom Salt, Eucalyptus Oil, Tincture Iodine, Tincture Benzoin Co.and Mercurochrome solution in containers not exceeding 100 ml, Tablets of Quinine Sulphate I.P., Tablets of Iodochlorohydroxy quinoline – 250 mg as per conditions mentioned in schedule
  • Cosmetics as per conditions mention in schedule
  • Ophthalmic ointments of the Tetracycline group of drugs as per conditions mention in schedule
  • Hair Fixers, namely mucilagenous preparations containing gums, used by men for fixing beard as per conditions mention in schedule
  • Radio Pharmaceuticals as per conditions mentioned in schedule
  • Tablets of Chloroquine Salts as per conditions mentioned in schedule
  • and Many more

Schedule J: Diseases which a drug may not purport to prevent or cure

Schedule A B C D E F G H H1 I J K M N O P Q R S T U V W X Y Z

Schedule J:

Diseases which a drug may not purport to prevent or cure.-

  1. No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure, one or more of the diseases or ailments specified in Schedule J. 
  2. No drug may purport or claim to procure or assist to procure, or may convey to the intending user thereof any idea that it may procure or assist to procure, miscarriage in women. Explanation.

Diseases and ailments (by whatever name described) which a drug may not purport to prevent or cure or make claims to prevent or cure.

  1. AIDS 
  2. Angina Pectoris 
  3. Appendicitis 
  4. Arteriosclerosis 
  5. Baldness 
  6. Blindness 
  7. Bronchial Asthma 
  8. Cancer and Benign tumour 
  9. Cataract 
  10. Change in colour of the hair and growth of new hair. 
  11. Change of foetal sex by drugs. 
  12. Congenital malformations 
  13. Deafness 
  14. Diabetes 
  15. Diseases and disorders of uterus. 
  16. Epilepticfits and psychiatric disorders 
  17. Encephalitis 
  18. Fairness of the skin 
  19. Form, structure of breast 
  20. Gangrene 
  21. Genetic disorders 
  22. Glaucoma 
  23. Goitre 
  24. Hernia 
  25. High/low Blood Pressure 
  26. Hydrocele 
  27. Insanity 
  28. Increase in brain capacity and improvement of memory. 
  29. Improvement in height of children/adults. 
  30. Improvement in size and shape of the sexual organ and in duration of sexual performance 
  31. Improvement in the strength of the natural teeth. 
  32. Improvement in vision 
  33. Jaundice/Hepatitis/Liver disorders 
  34. Leukaemia 
  35. Leucoderma 
  36. Maintenance or improvement of the capacity of the human being for sexual pleasure. 
  37. Mental retardation, subnormalities and growth 
  38. Myocardial infarction 
  39. Obesity 
  40. Paralysis 
  41. Parkinsonism 
  42. Piles and Fistulae 
  43. Power to rejuvinate 
  44. Premature ageing 
  45. Premature greying of hair 
  46. Rheumatic Heart Diseases 
  47. Sexual Impotence, Premature ejaculation and spermatorrhoea 
  48. Spondylitis 
  49. Stammering 
  50. Stones in gall-bladder, kidney, bladder 
  51. Vericose Vein.