-------------------------------------------------------------------------- | Add your name to the CLEAN GOA INITIATIVE | | | | by visiting this link and following the instructions therein | | | | http://shire.symonds.net/pipermail/goanet/2005-October/033926.html | -------------------------------------------------------------------------- This is in connection with Manguirish Pai Raikar's views on Schedule M that appeared in oHerald dated 24th October 2005, on page 3, which is connected with Pharmaceutical Industries. Let me first explain to general public on "What Schedule M is all about?"; "How & why Schedule M took birth in India?"; "Its benefits" and "what Manguirish is talking about!". Schedule M is a new provision to existing Drugs and Cosmetic Act of Government of India. The Schedule M deals with requirements of Good Manufacturing Practices, minimum standards required for manufacturing premises, plant and machinery, validation, procedures for operations, documentations, records maintenance, etc. for the pharmaceutical industries in India. With respect to Schedule M, there can and should never be two opinions about the need to implement this schedule to pharmaceutical industries in India considering the extremely poor manufacturing practices (including the pathetic conditions) followed by vast number of pharmaceutical industries in the country for several years now. I wonder how Manguirish does not know that it is these poor facilities and unhygienic environmental conditions coupled with no testing facilities at the company's premises that resulted in production of poor quality drugs for years together. Manguirish cannot expect "Cauliflowers to come out from garbage input - garbage in is garbage out holds equally true for pharmaceutical companies world wide" In fact improvising quality of pharmaceutical products in India was long over due and was put to stand still since than only due to these small scale industries. But how long general public should suffer from poor quality drugs just because of these small scale industries was a big question. Requirements of similar Good Manufacturing Practices (known by different schedule / section / rules) is made mandatory by western and other developing nations since more than past 20 years! This Schedule M was debated at length by all pharmaceutical companies (small, medium & big giants) including various pharmaceutical associations prevailing in India. Government of India redrafted the provision taking cognizance of comments received from them & finally approved the Schedule M as of 8th January 2002 for implementation from December 2003. Later due to after thought requests from various pharmaceutical companies and related associations the implementation was differed to 1st January 2004. Again, after January 2004 Government of India succumbed to these company's flimsy "ifs", 'buts" and other vagueness and very sympathetically yet again differed the implementation of schedule M from January 2004 to 1st January 2005 (differed by 1 year) as final date of implementation to which all companies and association had agreed as if it was a "consciences agreement".
All these various postponements to implement the new provision in Schedule M to Drugs and Cosmetic Act for nearly 3 years clearly indicate that Government of India did show sympathetic concerns to small scale pharmaceutical companies in India much beyond irritation and tolerance levels!! In reality and in the interest of the healthcare of general public execution of Schedule M should have be done immediately after its approval. In spite of all this background history, it's heartening to read what Manguirish is talking about on Schedule M! Existing Pharmaceutical units were given more than 4 years to gear up for compliance to Schedule M. And the way Manguirish puts it, it appears that Goa based small scale pharmaceutical companies never bothered to initiate compliance to this requirements! "Let's see when it becomes mandatory - till than let's continue to enjoy our profits" this must have been their attitude. Today we are in 3rd quarter of the year 2005 and none of the small scale pharmaceutical companies in Goa have raised their concerns with respect to Schedule M (and rightly how can they raise it?) but it's only Manguirish like their spokes person taking up for them that too unjustifiably, without any legal ethics in his arguments and that too after 3rd quarter of the year 2005. As regards testing laboratory which Manguirish talks about is not only the issue of Schedule M but was a requirement by law since past 10 - 15 years which is undisputedly accepted by all pharmaceutical companies (after lots of deliberations for number of years prior to making this rule mandatory)! And Manguirish is unwontedly unearthing past and also coupling up this issue only to Schedule M - his hidden agenda behind this might be to gain sympathetic monitory sanctions for his proposed in setting up Public Testing Laboratory with the financial aide from Government of Goa - I wonder whether if he is coming up with new venture in Public Testing Laboratory for small scale pharmaceutical companies! As regards his stand on Waste Management I believe it's not at all an issue of Schedule M in particular but is a legal binding clause between small scale industries in Goa and pollution control board of Goa and is in force since past 10 - 15 years. Presently Garbage and its Management is a big issue of Goa and yet Manguirish gives unwanted dimension to this issue too. By this stand does Manguirish mean to say that "Small Scale Manufacturers cannot cope up with their garbage? If so, why did they gave in writing to Goa Pollution Board that they will comply to Waste Management as per government guidelines - and now after obtaining license to start the small scale company are they trying to tell the Government that their economics don't permit them to spend money on their Garbage management!" Last but not the least, What was Manguirish doing for all these 3 plus years? Why did he not raise any of his concerns to Schedule M during those times? Does Manguirish mean to advocate that "The Schedule M being so stringent that small scale industries will have to close down their operations?" And just because small scale units are getting affected should government of India play with lives of general public? How can he justify the negligence attitude shown by these small scale manufacturers to gearing up for compliance with Schedule M for past 3 plus years? Or where all these so called small scale manufacturers thinking that Masiha in Manguirish will spring up to convince government of India to yet again differ its implementations or totally abolish the Schedule M? Manguirish is right on expressing his concerns about spurious drugs available in Goa. It is this issue that he and Goa Chamber of Commerce could take it up very strongly and come out with a plan (of course in consultation with FDA - Goa) to totally irradiate it from Goa. Can Go Chamber of Commerce do this? Can they at least take initiative in this regards? If so Goa and Goans will be proud of Manguirish and Goa Chamber of Comer and Industries. Let me pose these same questions in other way "Just because the requirements of Blood Banks are stringent for which, say, a particular unit don't comply with these requirements - will any one of us take transfusion of blood for themselves from such Blood Banks?" Knowingly the condition of Blood bank - Definitely Not! Why? - For every one of us is concerned with once life and health. That means heart to heart every one believes that such stringent regulations should be in place for health care products (blood and blood products included)! If this is so, then the next biggest questions come to mind is: Why is Manguirish giving unwanted press statements like Neetin did it other day suggesting Goa Government to consider investing money in three projects namely Disney land, Theme Parks, and entire Goa to be converted into Shopping Center!! According to Neetin these industries will boost tourism industries in Goa! On one side Neetin proposes investment schemes while Manguirish extends supporting hand to circumvent even the "absolutely required" rules / standards and also promises to get support from the government on his theories / proposals! Yes I do know that Manguirish and Neetin are inseparable thick friends. Like two sides of same coin! And both are also occupying respectable chairs in Goa Chamber of Commerce & Industries! Both are dynamic but using their dynamisms as per the political winds blowing in Goa!! What ever may be their theories of their preaching it does not allow them to use the powers of the chair to mislead and misguide general public and politicians alike! Whom are they trying to impress? Are they trying to convince the present ruling government that they are now on their side ideologically and wholeheartedly!! Or are their terms in Goa Chamber of Commerce coming to an end and that they are trying to seek re-appointments / re-nominations / re-election with the support of small scale industries and politicians! If so then they should be considered as politicians of first order than actual Politicians!! What are Manguirish and Neetin of Goa Chamber of Commerce and Industries personnel up too? Dr. U. G. Barad Margao - Goa
