PHARMACIST’S OATH

I swear by the code of ethics of Pharmacy Council of India in relation with the community and shall act as an integral part of health care team.

I shall uphold the laws and standards governing my profession.

I shall strive to perfect and enlarge my knowledge to contribute to the advancement of pharmacy and public health.

I shall follow the system, which I consider best for pharmaceutical care and counseling of patient.

I shall endeavor to discover and manufacture drugs of quality to alleviate suffering of humanity.

I shall hold in confidence the knowledge gained about the patients in connection with my professional practice and never divulge unless compelled to do so by the law.

I shall associate with organizations having their objectives for betterment of the profession of pharmacy and make contribution to carry out the work of the organization.

While I continue to keep this oath unviolated, may it be granted to me to enjoy life and practice of pharmacy respected by all, in all times!

But should I trespass and violate this oath, may the reverse be my lot!

Power of Entry, Search and Seizure

1. Any Gazetted Officer of the Central Government or of a State Government authorised by a general or special order by the Central Government or, as the case may be, by the State Govermnent in this behalf may, with a view to securing compliance with this Order or to satisfy himself that the provision of this Order have been complied with -

• enter and search any place,
• seize any drug, alongwith the containers, packages or coverings in which the drug is found, in respect of which he suspects that any provision of this Order has been, is being, or is about to be contravened, and thereafter take all measures necessary for securing production of the drug, containers, packages or coverings, so seized, in a court of law and for their safe custody pending such production;
• seize any document, such as, cash memo or credit memo books, books of account and records of purchase and sale of the drugs in respect of which he suspects that any provision of this Order has been, is being, or is about to be contravened.

    2. The provision of section 100 of the Code of Criminal Procedure, 1973 (2 of 1974), relating to search and seizure shall, so far as may be, apply to searches and seizures under this Order.

Power to review :
Any person aggrieved by any notification issued or order made under paragraphs 3,5,8,9 or 10 may apply to the Government for a review of the notification or order within fifteen days of the date of publication of the notification in the Official Gazette or the receipt of the order by him, as the case may be, and the Government may make such order on the application as it may deem proper :

Provided that pending a decision by the Government on the application submitted under the above paragraph, no manufacturer, importer or distributor, as the case may be, shall sell a bulk drug or formulation, as the case may be, at a price exceeding the price fixed by the Government of which a review has been applied for.

Power to issue guidelines and directions :

1. The Government, may for the purpose of implementing the provisions of this Order, authorise any Officer, by a general or special order, to inspect the premises of any manufacturer, importer, distributor or dealer and such manufacturer, importer, distributor or dealer shall allow such authorised officer and make available all relevant information required for the purpose.
2. The Government may, from time to time, issue such guidelines and directions, consistent with the provisions of this Order to any manufacturer or importer as may be necessary to carry out the provisions of this Order and such manufacturer or importer shall comply with such guidelines and directions.

Penalties :
Any contravention of any of the provisions of this Order shall be punished in accordance with the provision of the Essential Commodities Act, 1955 (10 of 1955).

Power to exempt :

1. Government may, having regard to the factors mentioned in sub-paragraph (2) and subject to such conditions as it may specify, by an order in the Official Gazette, exempt any manufacturer from the operation of all or any of the provisions of this Order.
2. While granting exemption under sub-paragraph (1), the Government shall have regard to all or any of the following factors -

• number of workers employed;
• amount of capital Invested;
• range/group and type of products manufactured;
• sales turnover;
• production of bulk drugs from basic stage by a process developed through indigenous research and development, and which is significantly different from known processes and results in cost reduction;
• production of a new drug which has not been produced elsewhere, if developed through indigenous research and development;

Delegation of powers :
The Government may, by notification in the Official Gazette, direct that all or any of the powers conferred upon it by this Order, other than those contained in paragraphs 22, 23, and 25 shall, subject to such restrictions, exceptions and conditions, as may be specified in the direction, be exercisable also by such Officer or authority as may be specified in the notification.

Repeal and saving :

1. The Drugs (Prices Control) Order, 1987 is hereby repealed.
2. Notwithstanding such repeal, anything done or any action taken, including any notification or Order made, direction given, notice issued or exemption granted under the Drugs (Prices Control) Order, 1987, shall, in so far as it is not inconsistent with the provisions of this Order, be deemed to have been done, taken, made, given, issued or granted, as the case may be, under the corresponding provisions of this Order.

sd/- 

Vinod Valsh 

Joint Secretary to

the Government of India 

(No. 5(4)/94-PI-II)

Display of Prices of Non-Scheduled formulations and Price List

1.Every manufacturer, importer or distributor of a non-Scheduled formulation intended for sale shall display    in indelible print mark, on the label of container of the formulation and the minimum pack thereof offered for retail sale, the retail price of that formulation with the words "maximum retail price" preceding it and the words 'inclusive of all taxes' succeeding it:

Provided that in the case of a container consisting of smaller saleable packs, the retail price of such smaller pack shall also be displayed on the label of each smaller pack and such price shall not be more than the prorata retail price of the main pack rounded off to the nearest paisa.

2.Every manufacturer or importer shall issue a price list and supplementary price list, if required, of the non-Scheduled formulations in Form V to the dealers, State Drugs Controllers and the Government indicating changes, from time to time.

3.Every retailer and dealer shall display the price list and the supplementary price list, if any, as furnished by the manufacturer or importer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

Control of sale prices of bulk drugs and formulations:

No person shall sell any bulk drug or formulation to any consumer at a price exceeding the price specified in the current price list or price indicated on the label of the container or pack thereof, whichever is less, plus excise duty and all local taxes, if any, payable in the case of Scheduled formulations and maximum retail price inclusive of all taxes in the case of non-Scheduled formulations.

Sale of split quantities of formulations :

No dealer shall sell loose quantity of any formulation at a price which exceeds the pro-rata price of the formulation plus 5 percent thereof.

Manufacturer, distributor or dealer not to refuse sale of drug :

Subject to the provisions of the Drug and Cosmetics Act, 1940 (23 of 1940) and the Rules framed thereunder -

• no manufacturer or distributor shall withhold from sale or refuse to sell to a dealer any drug without good and sufficient reasons; 
• no dealer shall withhold from sale or refuse to sell any drug available with him to a customer intending to purchase such drug. 

Price of formulations sold to the dealer :

1. A manufacturer, distributor or wholesaler shall sell a formulation to a retailer, unless otherwise permitted under the provisions of this Order or any order made thereunder, at a price equal to the retail price, as specified by an order or notified by the Government, (excluding excise duty, if any) minus sixteen percent thereof in the case of Scheduled drugs. 
2. Notwithstanding anything contained in sub-paragraph (1), the Government may be a general or special order fix, in public interest, the price of formulation sold to the wholesaler or retailer in respect of any formulation the price of which has been fixed or revised under this Order. 

Maintenance of records and production thereof for inspection

1. Every manufacturer and importer shall maintain in such form as may be specified by the Government, records relating to the sales turnover of individual bulk drugs manufactured or imported by him, as the case may be, and the sales turnover of formulations pack-wise and also such other records as may be directed from time to time by the Government and the Government shall have the power to call for such records or to inspect such records at the premises of the manufacturer or importer.
2. Every manufacturer or importer shall, within six months of the close of the accounting Year, submit to the Government information in respect of turnover and allocation of sales and expenses for that year in Form VI. 
3. Every dealer, manufacturer or importer shall maintain the cash memo or credit memo, books of account and records of purchase and sale of drugs and shall make available such records for inspection by the Government or any officer authorised in this behalf by the Government.

Can consumer ask for the price list of medicines being sold by a chemist/retailer ?

Ans. Yes. Every retailer is required to display the price list and the supplementary price list furnished by the manufacturer/ importer on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

Is it mandatory for a chemist/ retailer to issue cash receipt for sale of medicines ?

Ans. Yes. Every chemist/ retailer is required to issue a receipt for sale of medicines and maintain the copies of cash/ credit memos.

The Narcotic Drugs and Psychotropic Substances Rules, 1985

GSR 177(E) dated 24.3.2006-Narcotic Drugs and Psychotropic Substances (National Fund for Control of Drug Abuse) Rules, 2006 In exercise of the powers conferred by Section 76 read with Section 7A of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), the Central Government notified Narcotic Drugs and Psychotropic Substances (National Fund for Control of Drug Abuse) Rules, 2006, which will come into force from 24.3.2006. GSR 104 (E) dated 25th Feb, 2005 In exercise of the powers conferred by Section 9, read with Section 76 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), the Central Government has amended the Narcotic Drugs and Psychotropic Substances Rules, 1985,in the Rule 67 in sub-rule (1), for the word and figure 'Form 7", the word and figure 'Form 6" shall be substituted; after sub-rule 4, the following proviso shall be inserted, namely:- "Provided that consignment note in Form 6 shall not apply in cases where the sale of the psychotropic Substance is accompanied by a sale bill or invoice or cash memo or any other document duly signed by the consignor or his authorized signatory, which shall include the following information about the consignment: (a) name, address and licence number of the consignor and the consignee; (b) description, batch number and quantity; (c) mode and particulars of transport: Provided further that such document shall be preserved by consignor and consignee for a period of two years for inspection by the officers referred to in sub-rule (4) above. GSR 639 (E) dated 13.10.2006- Narcotic Drugs and Psychotropic Substances (Amendment) Rules, 2006

In exercise of the powers conferred by Section 76 read with Section 8 and 9 of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61of 1985) the central Govt made the Rules to amend the Narcotic Drugs and Psychotropic Substances Rules, 1985. The Govt has inserted a new provision after provision to Rule 66 (2), permitting individuals to possess more than hundred dosages for long term personal use prescribed by a RMP. In Chapter VII A in the heading “for medical and scientific purpose” the words “for medical, Scientific and training purpose” shall be substituted. After the Rule 67 A, new Rule 67 B (1) and 67 C are inserted. For existing Schedules I, II and III new Schedules are substituted.

GSR 736 (E) Dated 22.12.2005

Narcotic Drugs and Psychotropic Substances (Amendment) Rules, 2005 published to insert in Rule 36 (2A) after “Pholcodine and their respective salts” the words “from Indian opium, if the Central Government determines that such licence is necessary in public interest and is in consonance with India’s obligations under International treaties, conventions or protocols” .

GSR 633(E) dated 17-10-2005

In pursuance of rule 8 of the Narcotic Drugs and Psychotropic Substances Rules, 1985, the Central Government notified general conditions for grant of licence for cultivation of opium poppy on account of the Central Government during the Opium Crop year commencing on the 1st day of October, 2005 and ending with the 30th day of September, 2006.

GSR 634(E) dated 17-10-2005

In pursuance of Rule 5 of the Narcotic Drugs and Psychotropic Substances Rules, 1985, the Central Government notified tracts in the States of Madhya Pradesh, Rajasthan and Uttar Pradesh as the tracts within which poppy may be cultivated on account of the Central Government during the opium year commencing on the 1st day of October, 2005 and ending on the 30th September, 2006.

           

   

Amendment to Drugs & Cosmetics Act Deferred

IMPORTANT NEWS

The much talked about amendment in the Drugs and Cosmetics Act, that was to regulate the indiscriminate use of antibiotics, has been deferred by Union Health Minister Ghulam Nabi Azad. Health Ministry sources confirmed that at a meeting on Wednesday, the minister had decided on a review of the policy for the time-being.

The amendment would have introduced a new Schedule HX to the Act and would have made prescription-based sales compulsory for 74 listed drugs. Azad has reportedly said the policy that had been drafted by the office of the Drug Controller General of India (DCGI) — the drug regulatory authority under the ministry — was "not practical" considering the dearth of qualified doctors in rural areas.

"The amendment has not been dropped, it is just deferred for the time being," a ministry spokesperson confirmed. According to a senior official, "In the absence of sufficient number of doctors, making prescription-based sales compulsory for common drugs would affect patients adversely."

The schedule would also be compulsory for doctors to issue double prescriptions, one copy of which had to be retained by chemists for at least two years, while the other would be part of DCGI records, to check the over-the-counter sales of antibiotics.

These prescriptions would provide a suitable way to maintain a count of antibiotic use, which has been totally absent in the country. To regulate the availability of antibiotics, the schedule also lists 16 other drugs, which would have to be sold directly by the manufacturers to tertiary care hospitals.

Chemists had raised objections citing the lack of doctors and tertiary care centres in rural areas.

Duties of a Pharmacist

                           As a professional, the pharmacist has a duty of care to the patient both to supervise the sale of 'over-the-counter' (OTC) drugs which are available only in pharmacies and to dispense safely and correctly drugs which have been prescribed by a doctor. 

                                       OTC drugs may be unsuitable for an individual patient for a number of reasons. If approached for advice, the same duty lies on the pharmacist to counsel, warn, and act reasonably as it does on any prescriber. 

In addition, there is a duty to contact the prescriber if any question about a prescription arises.

List of Price Controlled Drugs (DPCO 1995)

SULPHAMETHOXAZOLE PENICILLINS TETRACYCLINE RIFAMPICIN STREPTOMYCIN RANITIDINE VITAMIN C BETAMETHASONE METRONIDAZOLE CHLOROQUINE INSULIN ERYTHROMYCIN VITAMIN A OXYTETRACYCLINE PREDNISOLONE CEPHAZOLIN METHYLDOPA ASPRIN TRIMETHOPRIM CLOXACILLIN SULPHADIMIDINE SALBUTAMOL FAMOTIDINE IBUPROFEN METAMIZOL (ANALGIN) DOXYCYCLINE CIPROFLOXACIN CEFOTAXIME DEXAMETHASONE EPHEDRINE VITAMIN B1 (THIAMINE) CARBAMAZEPINE VITAMIN B2 (RIBOFLAVIN) THEOPHYLLINE LEVODOPA TOLNAFTATE VITAMIN E NALIDIXIC ACID

GRISEOFULVIN GENTAMICIN DEXTROPROPOXYPHENE HALOGENATED HYDROXYQUINOLINE PENTAZOCINE CAPTOPRIL NAPROXEN PYRENTAL SULPHADOXINE NORFLOXACIN CEFADROXYL PANTHONATES & PANTHENOLS FURAZOLIDONE PYRITHIOXINE SULPHADIAZINE FRAMYCETIN VERAPAMIL AMIKACIN SULPHATE * GLIPIZIDE SPIRONOLACTONE PENTOXYFYLLINE AMODIAQUIN SULPHAMOXOLE FRUSEMIDE PHENIRAMINE MALEATE CHLOROXYLENOLS BECAMPICILLIN LINCOMYCIN CHLORPROPAMIDE MEBHYDROLINE CHLORPROMAZINE METHENDIENONE PHENYL BUTAZONE LYNESTRANOL SALAZOSULPHAPYRINE DIOSMINE TRIMIPRAMINE MEFENAMIC ACID *

Prescriptions Drugs

Prescription drugs are drugs that are not locally available without a physician's prescription. A prescription drug is a licensed medicine which is obtained only by prescription. The prescription drugs are regulated by legislation and different from over-the-counter (OTC) drugs which can be obtained without a prescription. They are also known as non-prescription drugs. 

List of Prescription Drugs

1.    Anti-Convulsant Drugs

2.    Anti-Obesity Drugs

3.    Anti-Angina Drugs

4.    Anti-Fungal Drugs

5.    Anti-Itch Drugs

6.    Anti-Viral Drugs

7.    Anti-Diabetic Drugs

8.     Anti-Asthamatic Drugs

9.      Anti-Hypertensive Drugs

10.    Antibiotics

11.    Anti-Migraine Drugs

12.    Anti-Rheumatic Drugs

13.    Anti-Protozoal Drugs

14.   Tricyclic Anti-Depressant Drugs

15.    Anti-Arrythmic Drugs

16.    Anti-Nausea Drugs

17.    Anti-Parkinson Drugs

18.    Anti-Psychotic Drugs

19.   Muscle Relaxants

20.    Digitalis Drugs

21.    Anti-Gastroesophageal Reflux Drugs

22.    Anti-Retroviral Drugs

23.    Anti-Tuberculosis Drugs

24.    Anti-Ulcer Drugs

25.    Anti-Hemorrhoid Drugs

26.    Anti-Spasmodic Drugs

27.    Anti-Malarial Drugs

28.    Non-Steroidal Anti-Inflamatory Drugs: Some can be bought over the counter; others are available only with a prescription from a physician or dentist.

29.    Immuno-Suppressant Drugs

30.    Anti-Insomnia Drugs

31.    Anti-helminthic Drugs

32.   Central Nervous System Stimulants

33.    Decongestants: Some decongestant products require a physician's prescription but there are also many non-prescription (over-the-counter) products.

34.    Anti-Coagulant Drugs

35.   Bone Disorder Drugs 

36.    Infertility Drugs

37.    Topical Antibiotics: Some topical antibiotics are available with a prescription only.

38.   Diuretics

39.    Vasodilators: In the forms used for treating high blood pressure (tablets or injections), these drugs are available only with a physician's prescription.

40.   Blood Viscosity Reducing Drugs

41.   Beta-Blockers

42.   Corticosteroids

43.   Benzodiazepenes

44.   Cephalosporins

45.    Expectorants: Some products that contain are available only with a physician's prescription

46.    Sulphonamides

47.    Calcium Channel Blockers

48.    Gout Drugs

49.    Antihistamines: Some Anti-histamine products are available only with a physician's prescription.

50.    Pencillins

51.   Barbiturates

52.   Laxatives

53.   Ace-Inhibitors

54.    Anti-Anxiety Drugs

55.   Urinary Anti-Infectives

56.    MAO Inhibitors

57.    Opioid Analgesics

58.    Bronchodilators

59.    Opthalmic Antibiotics

60.    Smoking Cessation Drugs: Some products are available only with a prescription.

61.    Protease Inhibitors

62.    Anti-Depressant Drugs

63.   Alpha1-Adrenergic Blockers

64.   Tetracyclines

Non-Prescription Drugs

Non prescription drugs are drugs that are sold over the counter, which means they are sold without a prescription from a doctor. These drugs are sold directly to the consumers as compared to prescription drugs, which requires a prescription. They are also referred as the over-the-counter (OTC) drugs. In the United States, there are more than 80 therapeutic categories of non-prescription drugs, ranging from weight control drugs to anti-acne to analgesic drugs and many more. These drugs are easily available in local chemists as well as in general stores, supermarkets, gas stations, etc.


Regulations of OTC Drugs


In many countries, OTC or non-prescription drugs are selected by a regulatory agency so as to check the ingredients that are used in the making of drugs are safe and effective when used without a doctor's advise. These non-prescription drugs are usually regulated by active pharmaceutical ingredients (APIs), not final products. This implies that the governments allow drug manufacturers the right to formulate ingredients, or combinations of ingredients, to make proper medicinal mixtures. Regulations related to who is authorized to dispense these drugs, to where they are to be sold, and whether a prescription is required vary considerably from country to country. In India. all the drugs that are not included in the list of prescription drugs are considered as non-prescription drugs (or OTC drugs).


Types of OTC Drugs or Non-Prescription Drug List


      1.      Anti-Hemorrhoid Drugs

2.      Topical Antibiotics: Some topical antibiotics are available without a prescription

3.      Cough Suppressants

4.      Anti-Acne Drugs

5.      Non-Steroidal Anti-Inflammatory Drugs: Some can be bought over the counter; others are available only with a prescription from a physician or dentist.

6.      Antispetics

7.      Analgesics

8.      Decongestants: Some decongestant products require a physician's prescription but there are also many non-prescription (over-the-counter) products.

9.     Asprin

10.  Vasodilators: Some Vasodilators such as Minoxidil are sold without prescription.

11.   Antacids

12.   Expectorants: Many expectorants are available without a physician's prescription.

13.   Anti-Fungal Drugs

14.    Anti-Histamines: Some can be bought without prescription.

15.    Anti-Gas Agents

16.    Smoking Cessation  Drugs: Many drugs can be bought over the counter, without prescription.

Characteristics of Non-Prescription Drugs

      Non prescription drugs usually have these characteristics:

      ·        The benefits of these drugs outweigh their risks.

      ·        There is low chances for misuse and abuse.

      ·        Consumer can use them for self-diagnosed health conditions.

      ·        These drugs can be adequately labelled.

      ·        There is no requirement of health professionals for the safe and effective use of the product.