Asian Journal of Biochemical and Pharmaceutical Research Issue 4 (Vol.

1) 2011

ISSN: 2231-2560
Research Article

Asian Journal of Biochemical and Pharmaceutical Research

Conceptual Comparison Between Schedule H And Hx Of Drugs & Cosmetics Rules, 1945: Strengthening Laws In Indian Scenario Ahuja Jitin 1*, Suresh Joghee1, N. Paramakrishnan1, Balaji Abhijin2 & P. Ahuja3
1Dept. of Pharmacognosy, JSS College of Pharmacy, JSS University, Mysore, India. 2Dept. of Pharmaceutics, JSS College of Pharmacy, JSS University, Mysore, India. 3 KIET School of Pharmacy, Ghaziabad, India

Received: 21 October 2011; Revised: 01 November 2011; Accepted: 10November. 2011

Abstract: The present paper deals with comparison between Schedule H and recently introduced Schedule HX of Drugs and Cosmetics Rules, 1945. Schedule HX has been introduced as a proposed solution to antibiotic resistance under the national policy for containment of antimicrobial resistance. Earlier the antibiotics were kept under Schedule H which should be sold by retail only on prescription of registered medical practitioner (R.M.P.) and in order to have separate regulation to check unauthorized sale of antibiotics a separate schedule HX is being introduced to regulate sale of antibiotic exclusively. Under this rule, about 90 odd antibiotic drugs are kept under two parts. Part A consists of 16 drugs like third generation antibiotics and all new molecules like carbapenams, daptomycin whose sale is now restricted directly to tertiary hospitals. Part B consists of 74 drugs which can only be sold against a duplicate prescription written by a R.M.P. and prescription is to be stored by the pharmacists for a period of two year, failing to which attracts penalty. This rule will help in check of irregular sales of antibiotics and hence, prevents the antibiotic resistance. Keywords: Schedule H, Schedule HX, Drugs and Cosmetics Rules 1945, Antibiotic resistance.

INTRODUCTION: Growing antibiotic resistance is a serious public health problem world is facing today due to its irrational use by the patients. Repeated and improper uses of antibiotics are two main causes for increase in resistant bacteria world over. It is estimated that up to 50 per cent of antibiotic prescriptions given in the community settings are not actually needed1. Currently antibiotics are placed under Schedule H of the rules and provide a uncontrolled access to patients which may lead to antibiotic resistance and increase in cost of therapy. Schedule H of Drugs and Cosmetics Rules, 1945 provides a list of drugs which are required to be sold on the prescription of a registered medical practitioner (RMP) and manufacturer is required to label the drug with the symbol Rx and with the following words: Schedule H drug Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

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Schedule H of the act consist a list of about 536 drugs which are required to be dispensed on prescription of RMP2. The third and fourth generation antibiotics will remain untouched by effective implementation of national policy for containment of antimicrobial resistance which discusses new policy and prevents these antibiotics from being misused. Schedule HX bans the over the counter sale of antimicrobials and hence a doctors advice become necessary for patient for taking the drugs falling under the schedule. According to Schedule HX, this has two parts, Part A and Part B. A total of 16 antibiotics in part A should be directly given by drug manufacturers to tertiary care hospitals and around 74 drugs in part B can be sold by pharmacist on prescription of RMP in duplicate3. The duplicate copy of prescription will be kept with the chemist for a further 2 year period. Drug inspectors in zonal and sub-zonal offices of CDSCO along with state drug inspector may conduct surprise raids at the chemist shops to ensure that the provision of Drugs and Cosmetics rules especially in respect of Schedule HX are strictly complied by the licensees adds the policy report for containment of antimicrobial resistance in India4. The objective of present paper is to compare schedule H and HX of Drugs and Cosmetics rules, 1945 with respect to new labeling requirements and regulations of sale and purchase of newer antibiotics. Differences in labeling requirements Schedule HX - Part A drugs will have a system of color coding for third generation antibiotics and all newer molecules like Carbapenems, Tigecycline, Daptomycin etc and will be marked For Use In Tertiary Care Hospitals Only. Part B of schedule HX has 74 drugs with a warning stating It Is Dangerous to take this Preparation Except in accordance with the Medical Advice and To be sold by Retail on the Prescription of a Registered Medical Practitioner Only. The color coding of different antibiotic will benefit consumers for identification of medicine. Schedule H5, 6 of rules provides a list of drugs to be sold on prescription of RMP. The container of medicine for internal use shalla. if it contains substance specified in Schedule H be labeled with a symbol Rx & conspicuously displayed on the left top corner of label & be also labeled with following words: Schedule H Drug - Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only. b. if it contains a substance specified in schedule H and comes with in the purview of the Narcotic Drugs & Psychotropic Substances act, 19857 be labeled with the symbol NRx which shall be in red & conspicuously displayed on the left top corner of label & be also labeled with following words: Schedule H Drug - Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

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c. container of an embrocation, liniment, lotion, ointment, antiseptic cream, liquid antiseptic or other liquid medicine for external application shall be labeled with the words in capital For External Use Only7. The schedule states that - the salt, ester, derivatives and preparation of substance in schedule H excluding those intended for topical or external use (except ophthalmic and ear/ nose preparation containing antibiotics and/ or steroids) are also covered by this schedule. The inclusion of a substance in schedule H does not imply or convey that the substance is exempted from the provisions of rule 122A/ 122B under Drugs and Cosmetics Act and Rules, 1945. The rule 122A and 122B states the application for permission to import new drug and application for approval to manufacture new drug other than the drugs classified under schedule C and C18. The same will be applied to Schedule HX. The only change will be in the rule 97 under Drugs and Cosmetics Act and Rules, 1945 which states about the labeling requirement of medicine mentioned therein. Violations under Schedule HX By incorporating Schedule HX under Drugs & Cosmetics Act, 1940 and Rules, 1945, the union health ministry wants to prevent the use of 70 odd antibiotics under national policy for containment of antimicrobial resistance. The Drug Control General of India (DGCI) office is authorized to audit these drugs at their own will. The new draft policy states a fine of rupees 20000 or imprisonment up to 2 years against those who violate the norms. The policy includes both the private and public sector players9, 10. Conclusion Introducing a separate Schedule HX that regulates the sale of antibiotics exclusively will rationalize the use of available antibiotics and reduce the chances of antibiotic resistance in patients of India. With implementation of new rule in the field, role played by registered medical practitioner (RMP) and responsibilities of the pharmacist will increase and further they can be held responsible for the decision they made. This in fact will have a powerful impact on sales of antibiotics which are available in only in tertiary care hospital and prescription written from intensive care units, inventory of hospital pharmacy as they have to store a considerable amount of antibiotics notified in part A of schedule HX, which will now being supplied directly to hospitals by drug manufacturers. The rules are applicable for both private and public sector players.This indeed improves the quality of living standard in India and strengthens the law and rules under therein. Hence, this fulfills the target of national policy for containment of antimicrobial resistance.

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Table 1 Comparison between Schedule HX and H of Drugs and Cosmetics Rules, 1945. S. No 1. Schedule HX Schedule H

Contains of two sub parts: Part A and Contains of about 536 antibiotics Part B consisting of nearly 80 odd with no regulation on its sales

drugs of third and fourth generation and are sold as over the counter antibiotics. 2. Labeling requirement: 1. Part A drugs can be (OTC) drugs Labeling requirement: 1. Schedule H drug

distinguished by color coding system and will be labeled as For Use In Tertiary Care

Warning: To be sold by retail on the prescription of a Registered Medical

Hospitals Only. 2. Part B contains around 74 drugs which will be labeled as It Is Dangerous to take this

Practitioner only. 2. Rx symbol on left top

corner of the label.

Preparation Except in accordance with the Medical Advice and To be sold by Retail on the Prescription of a Registered

Medical Practitioner Only. 3. Role of Pharmacist and RMP: 1. Pharmacist has to store the Role of Pharmacist and RMP: 1. Antibiotics OTC were sold as

prescription in duplicate for a time span of 2 years. 2. RMP has to write a duplicate prescription to patient. 4. Role of Drug Inspector and Role

product

without

prescription. 2. No such responsibility of RMP. of Drug Inspector and

CDSCO:

CDSCO:

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1. Zonal drug inspector and subzonal conduct pharmacy provisions CDSCO officers raid ensure under may on that the

1. Particularly for Schedule H no such procedures are

surprise to laid

mentioned in rules.

Schedule HX are followed or not. REFERENCES: 1. P.A. Francis., Pharmabiz.com., 2011, cited 2011 Sep 14.. 2. Anonymous., The Drugs and Cosmetics Act and Rules, 1945. Delhi: Ministry of Health and Family Welfare, Government of India., 2005. 3. V.R. Chowdhury., Express Pharma Online., 2011, (cited 2011 Sep 14). 4. R.K.Srivastava., National Policy for Containment of Antimicrobial Resistance - India. Ministry of Health & Family Welfare., 2011. 5. S.W. Deshpande, N. Gandhi., A Commentary on Drugs and Cosmetics Act, 1940 and Rules, 1945. 5th edition. Mumbai: Susmit Publishers; 2009, 456. 6. V. Malik., Law relating to Drugs and Cosmetics. 20th edition. Lucknow: Eastern book company; 2009, 409. 7. Ibid., p. 167. 8. Ibid., p. 176,177. 9. Anonymous., Health Ministry inserts Schedule HX under Drugs and Cosmetics Act. Indiamart.com., 2011, 149.

*Correspondence Author: Ahuja Jitin,Dept. of Pharmacognosy, JSS College of Pharmacy, JSS University, Mysore, India.

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