Food and Drug administration is an important department of the Government for protection of Consumer Rights and Social Health, It is under the control of Department of Medi- cal Education and Drugs, Government of Maharashtra. The Primary objective of this Administration is to implement vari- ous Acts for the control of quality of Drugs & Cosmetics and Safety of Food.
The Headquaters of Food and Drugs Administration is located at Bandra - kurla Complex, Bandra (E), Mumbai and offices at Divisional & District Places. The Commissioner is a Head of this Administration who is also notified as a Food Safety Commissioner under Food Safety and Standard Act 2006.
The regulations are implemented by the following independent section :-
(A) Drug Section
(B) Food Section
(C) Food and Drug Control Laboratories
(A) Drugs Section :–
Drugs are used to elevate the health of people and responsibility for the implemantation of various rules and regulations for getting the safe Drugs and Cosmetics, with good quality and purity to the people of the state, is assigned to food and Drugs Administrations.
For Drug Section, following Acts are implement by this Administration :
1) Drugs and Cosmetics Acts 1940 and Rules thereunder 1945
2) Drugs and Magic Remedies ( Objectionable Advertisements) Act’1954.
3) Essential Commodities Act’ 1955 thereunder Drugs Price Control Order’ 2013.
4) Narcotics Drugs and Psychotropic Substance Act’ 1985.
5) Poison Act 1919 and Rules thereunder and Maharashtra Poison Rule 1976.
To achieve the objective of better health of the society, following machinery is formed for the implementation of above Rules/Sub-Rule orders in the State:
State Level :-
Commissioner --------> Joint Commissioner ------> Asst.Commissioner --------> Drugs Inspector
Division Level :-
Joint Commissioner --------> Asst. Commissioner ---------> Drugs Inspector
District Level :-
Asst. Commissioner ------------> Drugs Inspector
For the control on Machinery which is implementing the above regulation in the State and for the effective implementation of these Rules, the intelligence branch is working on the State level which is under the control of Joint Commissioner ( Vigilance ).
Joint Commissioner (Vigilance)----->Asst. Commissioner (IB)-----> Drugs Inspector (IB) Head Quarters and Divisional Drugs Inspector (IB)
Following duties are performed by this Administration through the above machinery.
1) Drug Manufacturing
Manufacturing of drugs is a controlled process under the Drugs and Cosmetics Act 1940 and rules 1945. Allopathic Ayurvedic and Unani, Homeopathic drugs and cosmetics cannot be manufactured in the State without a valid Licence. It is mandatory to manufacture any Durg or Cosmetics under valid licence only. The licence is granted to the applicant who wants to manufacature the good quality drugs by following the provisions of GOOD MANUFACTURING PRACTICES as laid down in the ‘ Schedule’ M’ of Drugs and Cosmestics Act, with the specific condition of Licences. The three important conditions of manufacturing licence are -
1) Every drug should be manufactured under the active supervision of Competent Technical Person.
2) To ensure the quality of raw materials used for the manufacture of drugs, it should be tested in laboratory.
3) The manufactured drugs should be released after again testing it for its quality, only after assuring for its quality it should be released for marketing.
The divisional Joint Commissioners (drugs) are authorized as a licensing authority for the drugs manufacturing licence and Cosmetics manufacturing Licence. As per the law, inspections of these manufacturers should be carried out atleast once in a year and these inspections are carried out by the Drugs inspectors.
The responsibility to verify that, the drugs are manufactured in the State by following the provisions of Good Manufacturing practices is legally assigned to the Joint Commissioner ( Headquarter ) and as controlling Authority, he is responsible to periodically submit this assurance to Commissioner / Government.
Following are the drugs manufacturers in the State :-
Allopathic Drugs Manufactures - 854
Ayurvedic and Unani Drug Manufacturers - 435
Homeopathic Drug Manufacturers - 27
Cosmetics Drugs Manufacturers – 345
Drug manufacturing is an important business in the State and the drugs around Rs. 35332.65 crores is manufactured in the State in the year 2014-15.
Drug Export :-
The export of drugs from the State is not only generating the foreign exchange but also creating the employment in the State. Generally for the export of drugs, the manufacturer has to manufacture the drugs as per the provisions of Good Manufacturing Practices laid down by World Health Organization WHO GMP Certificates are granted to such manufactures by this Administration and these manufacturers can export the drugs. For the export of drugs to some of the developed countries, the permission of authorities of those countries is required eg. for America permission from USFDA, for England permission from MHRA. There are 230 Manufacturing and loan Licenses 323 Manufacturers in the State holding WHO GMP Certification , The export of the drugs from the State of Maharashtra is more than, export of drugs from any other State.
The quality Manufactured drugs in the State is Comparatively better and more demand from foreign countries.
For the promotion of drugs export form the State, Food and Drug Administration, Maharashtra State is the first in the country who has started granting online WHO GMP Certificates since 15th Aug 2012 and targeted to grant the certificates within 10 days after the valid application received and trying to achieve this target.
It is primarily speculated that in the year 2014 - 15, drugs about Rs. 15440 crores were exported from the State.
2) Drug Selling / distribution
The availability of the drugs for the patient is very sensitive issue and as most of the drugs are concentrated chemicals, the improper use may lead to serious adverse effects in the patients. In some cases death may be possible. For this, the sale/distribution of drugs is controlled and transfer of durgs right from manufacturing of the drugs, to wholesale drug selling, retail drugs selling till patient is controlled through the valid licence and compulsory biling.
Drugs are notified as an essential commodity under the Essential Commodity Act 1955 for the unintrrupted distribution of drugs and to avoid monopoly of manufacturers or the distributions. Any manufacturer or distribution or retailer cannot sale or distribution of any drug without a valid reason.
Drug is an essential ingredient for the treatment of mental and physical element of human being. if these ingredients are wrongly dispensed, it may be dangerous to human life. This is ascertained in the past centuries, hence in most of the countries of the world sale or distribution of the drugs are made compulsory under the active supervision of technical person for a careful and responsible distribution of drugs. This Provision is also included in Drugs and Cosmetics Act 1940 and Rules thereunder 1945.
The provisions which are made by Hon. Parliament of this country to avoid dangerous effect on health of the people are as below.
A) Sale of medicine only under supervision of Pharmacist
B) Sale of prescription drugs on the vaild prescription only.
C) Sale of drug by valid bills only
A) Sale of medicine under supervision of Pharmacist :-
Most of the drugs are concentrated chemicals which can cause ill effects on human body. Retail licence is granted only to those applicants who provide the services of registered pharmacist. The licence for the retail medical store cannot be granted unless this provision is complied. After the grant of licence the sale of drug shall be effected under the active supervision of registered pharmacist and prescription drugs should be sold by a vaild sale bills which is signed by Registered pharmacist. After the diagnosis by doctor, he prescribes drugs to the patient, the registerd pharmacist must verify the following requirements before dipensing the drugs to the patient :-
1) The Prescription is issued by a doctor and the doctor is competent to issue that prescription.
2) To guide the patient regarding the drugs prescribed by doctor and to confirm that drugs prescribed are specific to disease or else. And to verify whether the wrong medicine has been prescribed, so that the probable incidence of wrong name of drug can be avoided.
3) The dosage of drug prescribed by the doctor is appropriate on the basis of patient’s age, weight, gender etc.
4) The interaction of drugs on the other diseases other than the targeted disease.
5) If more than one drug is prescibed, to check there is no adverse effect bacause of drug-drug interaction.
6) The dose regime should be advised to the patient.
7) Counseling to the patient on the importance of completing the dose regime of drug.
If above requirement are not complied because of the absence of pharmacist in medical store, it may cause ill effect to human health. Though the system of measuring these adverse effects is not developed in the State, comparing the figures in developed countries, the incidences of adverse effects are remarkably high. To avoid this and to protect the health of the people in the State, it is the responsibility of Food and Drug Administration that, the sale of the medicines by way of retail shall be effected under the presence of registered pharmacist only. For contravention of this important provision the licences are cancelled to save the precious life of patient. The detailed information about the action of cancellation of licences due to absence of pharmacist is given in Drug table No. 2-C.
B) Sale of prescription drugs on the valid prescription only :-
Doctors’s prescription is compulsory for the specific drugs in India, as it in the most of the countries of the world. Doctors are competent enough to prescribe the drugs to the patient because of their strong scientific study and knowledge in this regard. Prescription drugs are effective only if they are taken carefully.if drugs are not taken as per prescriptions it may be dangerous to the health of patient or may lead to other complications and in some cases it lead to death of patient . The ill effect of self medication can be seen not only on the patient but also it can develop a strain of drug resistance micro - organism which are difficult to treat by other available drugs. This effect can percolate on next generation as well. This situation is extremely serious which is also strictly observed by World Health Organization and other developed countries. The sale of the Scheduled Drugs (prescription) should be effected on a vaild prescription only is a prominent provision of Drugs and Cosmetic Act. 1940 and the responsibility lies on the food and drug Administration to implement and verify its compliance. This provision is strictly implemening from the year 2012 - 2013.
C) Sale of drug by valid bills only :-
To assure the availability of quality drugs to patient and to avoid the incidences of Adverse effect of substandard drugs which are sold and manufactured in the State are regularly tested by this Administration. To avoid the use of substandard drugs and its further ill effect, it is expected that these drugs should be recalled from the patient. This is only possible if the record of sale of such a drug to a particular patient is available with retail drug store. By considering this fact, central Government had made mandatory provision in the Act for maintenance of second copy of sale bill of a prescription drugs with the retail drug store. if recall of drug from a patient is required, it will be possible through the address of the patient recorded on the sale bills. if the sale of medicines are effected without a bill or reqired details are not mentioned on bill, the patient’s life will be on stake because of substandard medicines.
As drugs are comparatively costlier, to avoid the possibillity of manufacturing and sale of spurious drugs by the anti social elements, the provision of issuing a valid sale bill is mandatory as per Act. The posibillity of sale of spurious drugs to the patient cannot be rooted out if the drugs are sold without a vaild sale bill. Hence this provision is carefully included in the Act. Food and Drug Administration is responsible for enforcement of such provision of the Act. The strict implementation of this is carried out from the year 2012-1013. Those retail licencee who are not following these provisions strict like suspension and cancellation is taken by the Administration.
(3) Control on Price Drug (Drugs Price Control Order’ 2013)
To control the exorbitant prices of the drugs, Drugs Price Control Order’ 2013 is introduced by the Central Government under Essential Commodities Act ‘1955. Central Government has passed the Drug Price Control Order ‘2013 which is applicable from 15th May 2013 in the entire country. Prior to this amendment, Drugs Price Control Order’ 1995 existed, which controlled the prices of only 76 drugs, however in the amended order 348 essential drugs are covered for the price control. Thus the patients are benefitted with the affordable cost of 348 drugs.
(4) Drugs and Magic Remedies (ObjectionableAdvertisements) Act’ 1954
To control the advertisement of drugs, Administration enforces Drugs and Magic Remedies (Objectionable Advertisements) Act’ 1954. As per the provision of this law, the advertisements which contain false and misleading statement and are harmful to the people or may cause financial loss to the common people, broadcasting in the print and electronic media are controlled. Administration carried out special drive against these types of advertisement and initiated action against various T. V. Channels and concerned peoples, actors, news paper and in some cases FIR has been launched in police station.
(B) Food Section :- The Food Safety and Standards Authority come in to force from 5th August 2011. By implementation of Rules and Regulations under the said Act. It has created a possibility of getting trusted and wholesome, quality food for the citizens in the State of Maharashtra Implementation of the said act has created following actions which are–
(1) Registration of Food Business Operators/On line Registration of FBO.
“Even though a survey is not done for how many Food Business Operators are in the State of Maharashtra. But there are huge number of Food Business Operators For their Conversion/Renewal From Prevention of food Adulteration Act to Food Safety and Standards Act (FSSA), as per the extended time line up to 4th February 2016. Accordingly, in the year 2014-15 total of 31,569 Licenses and 316,061 Registration of food Business Operators were done where as in the year 2015 -16 until March, 2016, 33314 Licenses and 100976 Registrations of Food Business Operators were done under FSSA. In this Manner, from 05 August , 2011 till 30/11/ 2014, total 171736 Licenses and 594873 Registrations of Food Business oprators were done under FSSA”
(2) Administrative Improvement-
In the State of Maharashtra for Food Sector State Govt (Food and Drug Administration), Municipal Corporation and Corporation i. e. These three bodies where the controlling authority for check on quality of food. But from 5th August 2011, FDA is the only body for Implementation of the said act not the Municipal Corporation and Corporation. By considering the density of FBO’s and Geographical conditions, areas are notified in the State of Maharashtra vide G. R. No.असुका/कार्यक्षेत्र/मरावऔप्र/अपुअ-44-12/7 दि. 19 जानेवारी 2012, the responsibilities of Food Safety and fixed upon the Food Safety Officers and Designated officer of the said notified areas.
(3) Implementation of Food Safety and StandardsAct.
It is manditory for Food Business Operator to develop his own Food Safety management system and implement before registering under the act. If the FBO is not following the Food Safety Management System, he is issued Improvement Notice and even if he is not following the FSMS action is initiated against the FBO. This action also been started in the State. Compouding action under the said act for petty vendors is also intiated in the State for Improving them qualitywise. For those who are big FBO and does not carry out their business in accordance with the said act for then prosecution along with Adjudication action is initiated For this all actions State of Maharashtra is leading with Country.
(4) About Food Creating Health Hazards human health.
Food creating Health Hazard for citizens in the State or those food which are unsafe for human life, for such foods, provisions are made in the said act. By utilising such powers the Food Safety Commissiner can prohibit such food activities upto a period of one year.
In the year 2013-14 and 2014-15 Gutkha, Panmasala, Scented Tobacco and scented Supari etc. causing Health Hazard of Human life such as Acute Hyper Magnesia, Cardiac arrest, Oral Submucos fibrosis, oral cancer, leukoplakia, esophagean cancer/ stomach cancer, Metabolic abnormalities reproductive health, Gastro Intescial and Respiratory diseases. Many States in the Country has prohibited such of food articles but State of Maharashtra is the leading in the Country for such action.
The informantion regarding Registration of FBO, Improvement notices, Compounding, Amount Adjudicating amount and year wise action taken with respect to Food Licenses etc is given in Appendix Food Table No. 1 to 13 for the State.
(5) regional Controlling in the State.
Whether the said act is being accuratly and properly implemented or not in the State, can be found out by a system which is in details and includes per month controlling and Review (Appendix) because of the said system Head Quarter makes efforts for obtaining. Higher level of Implention of the said act.
In the State by way of E-Governance online Registration of Food Business Operator by being started from 22nd March 2013 in the State.
(C) Drug and Food Control Laboratories, Maharashtra State
For the availability of quality drugs and food to the people of State, Food and Drug Administration also take action against the traders, who introduced their substandard product in the market and prohibit to develop this culture in the State. The part of this procedure is a sampling, where Food Inspectors are targeted to draw 5 sample and Drugs Inspectors are targeted to draw 4 samples per month for the year 2014-15. The samples of Food and Drugs drawn by the inspectors are analyzed by the Drugs Control Laboratory situated at Mumbai/ Aurangabad. Administrative of legal actions are initiated on the food or drugs which are declared substandard.
(1) Drugs Samples
During the period of last 4 years i. e. from 2009-2010 to 2012-2013, 28,521 samples were drawn for test and analysis out this 1848 samples found to be not of standard quality drugs. The percentage of not of standard quality drugs manufacured by manufacturer in the state is 2-3.77%. The percent of not of standard quality drugs manufactured by manufacture other than state of Maharashtra but drugs sold in Maharashtra State is 7-12%.
From the above figures it is evident that, he quality of drugs manufactured in Maharashtra is of good quality than any other state.
It is expected that, not of standard quality drugs should to be recalled immediately from consumers, retailers and wholesalers to avoid ill effects on health of the patients. Considering the past experience. it was observed that about 2-3, months time was consumed to declare the results of analysis. And there was a possibility of consumption of entire stock of the drugs by the patient. Now this procedure is entirely changed and procedure of declaring the results with 3 days or 15 days (as per the situation) has been started. The procedure of declaring the results of Not of standard quality drugs is also been changed Proviously it was forwarded to concern Drugs Inspector, however from the year 2012-2013 the result of Not of standard quality drugs are forwarded by Government Analyst to all the Drugs Inspectors, Assistant Commissioner, Joing Commissioner, Commissioner, all state Drugs Controllers and also to print and electronic media via email. By following this procedure it is easier to recall the Not of standard quality drugs from the patients and also from the markets. The detail information regarding receipt of samples and their analysis report from Mumbai and Aurangabad Laboratories are as per Drug Table No. 6.
To increase the capacity of analysis of food and drugs samples in the State, and to minimize the time required for the analysis, process is initiated for the expansion of the existing laboratories at Mumbai and Nagpur and establishing new laboratories at Pune, Nagpur, Kolhapur, Thane, Nasik, Amravati is in progress.