The Drug Control Wing was established in the State in the year 1964 under the administrative control of Directorate of Health Services, J&K and remained so till the year 1987. In the year 1987, A full fledged Organization of Drug and Food Control came into existence after its bifurcation from Directorate of Health Services J&K, with an objective of ensuring availability of standard, safe & quality drug and food articles to the public.
Background:
Drugs and Food Control Organization was a part of Directorate of Health Services until 1987 when a full flagged organization came into existence, primarily to check the quality of Drug and Food Articles. The concept of FDA has been presumably conceived from similar arrangement that existed in some other progressive States of the country. However the infrastructure and Human Resource available in the Organization remained more or less unchanged until 2007 when at the behest of Court directions, sanction was accorded to the creation of 72 posts of Drug Inspectors, 07 posts of Assistant Controller Drugs, 09 posts of Assistant Controller Food, 02 posts of Public Analyst and 01 post of Drug Analyst in order to Augment the Technical Man Power in the Organization. This was followed by creation of 04 no. posts of Assistant Controller Drugs by corresponding reduction of 04 no. posts of Drug Inspectors in the year 2011 for placing the same as Staff Officers to the State Head (02 posts ) and Divisional Heads (01 Post each).
The Department was also implementing the repealed PFA Act, 1954 till 05.08.2011 with the help of around 106 Food Inspectors. These Food inspectors were working under Block Medical Officers in the Health Deptt who were functioning as Local Food Health Authorities. However the Food Safety and Standards Act, 2006 came into force from 5.08.2011 and replaced multiple food laws, standard setting bodies and enforcement agencies with one integrated food law. The FSS Rules and Regulations also came into force with effect from 05.08.11. The Acts and Orders that were repealed when the FSS Act came into force are the Prevention of Food Adulteration Act, 1954, the Fruit Products Order, 1955, the Meat Food Products Order, 1973, the Vegetable Oil Products (Control) Order, 1947, the Edible Oils Packaging (Regulation) Order, 1998, the Solvent Extracted Oil, De oiled Meal and Edible Flour (Control) Order, 1967, the Milk and Milk Products Order, 1992. The objective of the FSS Act is to consolidate the laws relating to food and establish the Food Safety and Standards Authority of India for laying down science based standards for articles of food and regulating manufacture, storage, distribution, sale and import of food articles to ensure availability of safe and wholesome food for human consumption. The challenges that the Act seeks to address include movement from multilevel and multi-department control to a single line of command, with FSSAI being a single reference point for all matters related to food safety throughout the entire food chain, a unified licensing system, encourage self-compliance, provision of graded penalties based on severity of offence together with a mechanism of speedy disposal of cases, focus on food safety, and harmonization between domestic and international food policy issues without compromising on public health and national interest. The regulatory mechanism under the New Food Law has been mainly entrusted to the Drugs and Food Control Organization (DFCO) as 23 Officers/officials belonging to the Cadre have been appointed/ notified as Designated Officers and placed in Districts (01 for each District). Similarly out of 87 Food Inspectors who have been notified as Food Safety officers 71 belong to DFCO. The two Food Testing Labs responsible for test and analysis of Food Articles also belong to DFCO. In order to put in place an efficient and responsive regulatory hierarchy the Govt realized to partly implementing the recommendations of Central Advisory Committee constituted under Section 11 of the Food Safety and Standards Act, 2006 and accordingly accorded sanction to the creation of 36 more posts in the Food Side which includes 02 posts of Deputy Commissioner of Food Safety, 12 posts of Assistant Commissioner, 04 posts of Assistant Food Analyst and 04 posts of Lab. Technician for augmentation of technical human resource. The Government is actively considering to bring eligible functionaries performing the duties of Food safety Officers and presently working under the administrative Control of Municipal corporations (09 Food inspectors) and Director local Bodies Jammu (07 Food inspectors) under unified control to fulfill the mandate of single line administration advocated by the New Food Law.
In nut shell there are 53 Gazetted Officers responsible for effective implementation of following regulations/orders inforce:
- Drugs and Cosmetics Act 1940 and Rules 1945.
- Food Safety and Standard Act, 2006 and Rules and Regulations, 2011
- Cigarettes and other Tobacco products (Prohibition of Advertisement & Regulation of Trade and Commerce, Production, Supply and distribution) Act 2003.
- Drugs Price Control Order, 1995 (under the Essential Commodities Act).
Besides there are 84 Drugs Inspectors (24 deputed to Drug testing labs) and 106 Food Inspectors (06 deputed to food Testing labs) who are supplementing enforcement of above said Laws/Orders in vogue.
The budgetary allocation under the 11th plan is briefly summarized as under:-
Year |
Plan |
Non-Plan |
||
Allocation |
Utilization |
Allocation |
Utilization |
|
2007-2008 |
110.00 |
54.11 |
498.20 |
395.65 |
2008-2009 |
132.00 |
117.00 |
535.43 |
419.49 |
2009-2010 |
282.00 |
249.17 |
599.23 |
541.83 |
2010-2011 |
448.04 |
430.81 |
697.06 |
663.96 |
2011-2012 |
498.96 |
489.55 |
847.85 |
809.31 |
One of the main interventions of the State Government to achieve its Public Health Objectives is to ensure that Drugs available to the Public are safe, efficacious and conforms to the prescribed quality standards. Drugs are the greatest weapons of the mankind to fight diseases and death, and Drug Control is the only tool to ensure highest quality and purity of Drugs. Under the Drugs and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the state authorities while the Central authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for drugs, control over the quality of imported Drugs, coordination of the activities of the State drug Control Organization and providing expert advice with a view of bringing about uniformity in the enforcement of the Drugs and Cosmetics, Act.
Drugs Controller-general of India is responsible for approval of licenses of specified categories of drugs such as blood and blood products, I.V. fluids, Vaccine and sera.
The functions under taken by the State Drug Control are briefly summarized as under;-
- Licensing of drug Manufacturing and Sales Establishments (Retail/Wholesale).
- Licensing of Drug Testing Labs.
- Monitoring of quality of Drugs and Cosmetics manufactured and marketed in the State.
- Approval of Drug Formulations Manufactured within the State.
- Investigations and prosecutions in respect of contraventions of legal provisions
- Administrative actions.
- Pre and post-licensing inspections.
- Recall of substandard Drugs.