Combined Food and Drugs Laboratory

The Food and Drugs Laboratory, Pasteur Institute, Shillong was set up 20 years ago to cater to the needs of the public and the society as a whole so that the food that we eat or drink and the medicines that we use for medication conform to the standards laid down by the Government of India in statutory guidelines viz, Prevention of Food Adulteration Act, 1954 and respective pharmacopoeias claimed by manufacturers on any of their manufactured products. Water meant for drinking - natural, mineralized or packaged drinking water should be free from bacteria and germs and should also have appropriate chemical properties such that it should be fit for human consumption. Devising accurate testing procedures on the specific conformities of food and food products to their respective standards and on complex dosage formulation of drugs containing several therapeutically and chemically, compatible components with very similar nature is a tantamount task. On the drugs sector not only are the multiple active constituents present in medicines are to be accounted but their usually divergent concentrations depending on their relative potency and therapeutic need of the patient further complicates selection of a method one should undertake to obtain reproducible results. The official compendias are rarely of help in such formulations. The presence of additives, excipients and decomposition products aggravates the mindset of analyst in finding a solution to develop a procedure with minimum interference due to their incorporation.

Both the Food and Drugs Laboratory have a common irrefutable obligation as most of the classical methods of analysis on food or drugs which were considered precise, simple and within the limits of analytical tolerance are no longer preferred. Newer methods which involved use of sophisticated instruments have been included in official compendias and manuals on food analysis. Handling of these expensive equipments require highly specialized personnel who had been trained to operate them. Modern analytical techniques using sophisticated instruments permit analysis to be carried out more rapidly than the conventional methods which are in fact tedious and time consuming. But laboratories which are equipped with these sophisticated instruments are also to maintain them in working condition which is indeed a Herculean task.

In view of the rapid advance during the last few years in the marketing of the ever - increasing multi-component formulations, the Drugs Laboratory is thoroughly engaged in the last 10 years or so hunting for procedures in journals like the Eastern Pharmacist, Indian Drugs, Indian Journal of Pharmaceutical Sciences. etc., some of which we are still subscribing but due gratitude should be given to Dr P.D. Sethi, an expert on pharmaceutical analysis for his contribution in this field by publishing three editions of his books viz "Quantitative Analysis of Drugs in Pharmaceutical Formulations" and also the two editions of another set of books on how to identify various components in a formulated dosage form by a technique called Thin layer Chromatography. But in spite of all these resources, an analyst in the Drugs laboratory who is in need of an analytical method has to survey a massive amount of literature from standard textbooks on drugs analysis and publications in international journals through the Internet so as to select a procedure which may appear to suit his need according to the laboratory facilities available. The staff of the Drug Testing Laboratory has compiled an SOP for almost all the drug combinations or formulations received so far in the form of a book after going through all these exercises so that when the selected procedure was put into test, one does not have to repeat the analysis on that particular sample by comparing with another procedure as the method selected is expected to give reliable results and should be best suited for routine quality control and is capable of being performed by personnel with minimum technical training or experience and under reasonable laboratory facilities. But that is not always the case, as drug formulations with the same composition may come in different forms or vehicles viz, as tablets, capsules, syrups, suspensions, injections etc. where respective concentration of active principles vary from one another and excipients, additive and decomposition products also play a role on the success of that analytical procedure selected.

It is note worthy to emphasize that methods selected through our experience should be one that does not involve the use of Reference Substances as because of the fact that these substances are available only at the Central Drugs Laboratory Kolkata free of cost and has to cater to the requirements of Drug Testing Laboratories all over the country and also to Drug manufacturing companies in private and government sectors. Request for the supply of these Reference Substances which are essential to compare the results when sample and standard were conducted simultaneously to quantitate the percentage purity of sample, are being sent on a regular basis to the Central Drugs Laboratory in batches of 10 for which, if one receives 6 of these items asked for, that too a few hundred milligram each, one should consider himself to be lucky. Working Standards or Substances manufactured by private drug manufacturing companies are too expensive and these companies are always not in a position to supply them in conditions desired by us.

Maintenance and Calibration of analytical instruments in the Food and Drugs Laboratory is also being looked after on a routine basis. Instruments like the HPLC, UV-Visible spectrophotometer, pH meter, Karl Fisher Titrater, potentiometer, Tablet or Capsule Dissolution Apparatus, Tablet or Capsule Disintegration Apparatus, Melting point Apparatus, etc., are calibrated regularly so that the results obtained in our daily routine analytical work are valid and acceptable within the scope of their performance. SOPs on the steps to follow while using these instruments are also maintained. In view of all the in paragraphs above, the staff of this laboratory had been able to analyze all the food, drug, water and salt samples sent by respective inspectors or brought by private parties (water and food only) with whatever facilities available and is looking forward to improve and upgrade its working capacity as the posts of Microbiologists and Assistant Analyst (Food Section), have been recently created by the Government of Meghalaya to meet this challenge.

Performance during the years 2004-2005 to 2008-2009

Food Section

	2004-2005	2005-2006	2006-2007	2007-2008	2008-2009
Food Samples	75 numbers 56 numbers Nil	46 numbers 51 numbers 98 numbers	70 numbers 25 numbers 14 numbers	Nil  Nil  Nil	Nil Nil   4 numbers
a) PFA Samples b) Informal Samples c) Private Samples
Water Samples	326 numbers 430 numbers	420 numbers 418 numbers	536 numbers 451 numbers	625 numbers 532 numbers	591 numbers 451 numbers
i) Private Samples (a) Chemical Analysis (b) Bacteriological Analysis
ii) Government Samples (a) Chemical Analysis (b) Bacteriological Analysis	14 numbers 10 numbers	16 numbers 15 numbers	16 numbers 15 numbers	3 numbers 7 numbers	Nil Nil
Salt Samples	10 numbers	24 numbers	7 numbers	Nil	53 numbers

Drug Section

	2004-05	2005-06	2006-07	2007-08	2008-09
Drug Samples	2 numbers 213 numbers	Nil 211 numbers	3 numbers 257 numbers	1 Number 175 numbers	1 Number 280 numbers
Legal Samples Survey Samples

Steps taken

Vacant post of Public Analyst is yet to be filled up since the retirement of the last incumbent. The Government has been moved to speed up the matter for smooth functioning of the laboratory, which the Government has taken up seriously.

• Proposal sent to the Government for the following:-
• Upgradation of the post of Government Analyst to Jt. Director of Health Services (Research).
• Promotion of senior most Chemist to Assistant Analyst.
• Advertisement of sanctioned post of Microbiologist.

Steps to be taken

Proposal to be sent to the Government for the following:-

Name of Post	Existing Sanctioned Post	Proposal	Remarks
Assistant Analyst	1 number	1 number	By promotion from amongst the senior most, experience and qualified incumbent working in the Drug Laboratory
Chemist	1 number	1 number
Assistant Chemist	1 number	1 number