National Pharmaceutical Pricing Authority and Ministry have messed up everything was all along suspected but honeymoon is so perfect was not known. The following message from Delhi to Mumbai shows that operation which NDA has been avoiding needs to be done:-
“Please be informed that yesterday I was able to meet Mr. Amarpal Singh Sawhney who is working as a Director (overcharging and legal), NPPA. He said that there is procedure for giving personal hearing in NPPA and irrespective of the questions asked NPPA is not going to change its stance on these matters even if the ministry is involved. He said the ministry always forwards those letters( letters sent to the Secretary) to NPPA for their comments and there is no value addition from their side and totally relies on NPPA and in a way supports the view of NPPA.
The only option for us is to pay the amount or get the court involved in the matter. They are now going to send the recovery notice to the collectors office in coming days, may be within a weeks time.
Even if we get a personal hearing from the NPPA based on the courts direction their contentions will remain the same as is clear from above and they are going to raise the demand notice with revised amount ( as the period increases ).
If we have a personal hearing from the DOP as a reviewing authority, as done in Alembic case, we can hope for some relief. But this has to be done through courts instructions and our efforts should be focused on that, rather than getting a personal hearing from the NPPA.
Sir, this Jenkburt case is it the case ( writ petition 299 of 2013 ) which was decided on Aug 2013? This judgement talks about the power of NPPA to review its own orders. Only the ministry has the power to review, the NPPA is expressly barred from doing so.”
2. The message is that NPPA is so strong that it does not bother about the Ministry, Ministry relies on NPPA and in a way supports NPPA views, NPPA is not going to change its stand in hearing and Ministry is also not going to intervene unless there is a Court order. In fact NPPA and Ministry were on the same side of corruption during UPA regime and their objective was to make money from the big companies and show honesty by troubling SME’s. The assets of those who are and were in position run into crores of rupees through ill gotten wealth and at least investigation against few should have been ordered. Both NPPA and Ministry have been pushing the companies to the courts is clear from above. Ministry is a partner instead of discharging its role as overseeing authority. It is also clear that NPPA is free to refer everything to the Collector and is the sole decider although no such power have been delegated to it. As a result all the courts are flooded with court cases be it Shimla, Chandigarh, Chennai, Bangalore, Supreme Court etc. What goes of their father it is Govt which is getting bad name, bad name and nothing else and everybody gets convinced that Govt is intolerant. In the Ministry there is Mr Pant Joint Secretary, Mr Maggo and Secretary who go together to the Minister as individually they cannot explain anything. It is understood that Mr Pant is already being investigated for wrong doings in Rajasthan, he keeps designers pens worth lakh of rupees each in his pocket and wears watches worth Rs. 4 lakh each but has no control over anything and even after over one and a half year he continues to be novelty. Recently, Mumbai High Court based on its experience of dealing with NPPA and its let loose agents has delivered a judgement stating that doer cannot be the reviewer/decider and rightly so. We are sure that other Courts including the Supreme Court will follow suit instead of keeping matters pending with them or deciding them wrongly under pressure as have been happening so far. Prime Minister should ensure that there should not be highhandedness of the type practiced by NPPA and Ministry with his Ministers just sleeping and passing time. They must learn to act and act sternly. Will the PM and his Ministers wake up to this reality or the monster will continue to do whatever it is doing?
3. we now invite attention to the fact as to how they are discouraging production. Paragraph 5 of Drugs(Prices Control) Order, 2013 provides for approval of retail prices of formulations based on dosage and strengths other than those in the First Schedule but containing those drugs as are in the First Schedule singly, in combination or in combination with drugs not in the First Schedule when introduced by the existing manufacturers after the commencement of DPCO, 2013. For the purpose of seeking approval to the retail price details in Form I of the Second Schedule to the DPCO, 2013 are required to be submitted by the manufacturers. S.No 5 of the said Form I provides as under:-
“5.Drugs control Authority Permission No. and date(copy to be enclosed)”
4.NPPA issued Office Memorandum No. 19(78)/2013/DP/NPPA/Div II dated 28th Dec, 2014 prescribing that cases where manufacturing permission was given prior to 1st Oct, 2012 and /or renewal thereafter under Drugs and Cosmetics Act, 1940 will continue to be in operation. Thereafter, two more OM. Nos.19(78)/2014/Div II/NPPA dated 10th Feb, 2015 and O,M.No.19(7*)/2014/Div II/NPPA dated 24th July, 2015 were issued emphasizing that name of marketer be also got endorsed on the manufacturing licence. Both the OM’s are self explanatory and clearly show that what was required to be done through Ministry of Health and Family Welfare by DCG(I) was sought to be enforced through forum of NPPA that too in a wrong manner against the letter and spirit of DPCO, 2013 and Form I prescribed there under. Clearly no body is bothered about production, utilization of facilities and all these things in which NPPA indulged or is indulging was not their mandate. This is happening because NPPA is negatively dealing with the issues of such great concern to the country as well as the industry. If this was to be done Form I should have specified it. Everything was OK till Dec, 2014 and there was no such requirement despite the fact that DPCO, 2013 was announced in May, 2013. The companies pleaded that requirement of getting the manufacturing licence endorsed with the name of marketer was put in place in 2015 and as such applications which were pending even before 2014 should not be linked as any change has prospective effect but this plea was also rejected. These aspects warrant a serious scrutiny by the Ministry/ PM to ensure that such instances are not repeated.
5/The basic issues on which we seek response are:-
(a) When S.No.5 of Form I under DPCO,2013 has simply laid down that Drugs Control Authority Permission Number and date(with copy) is to be given and this document is issued by the Govt any deviation by the delegate which have far reaching implications should not have been allowed but this aspect may be settled by the Ministry and NPPA may be directed to withdraw all its instructions referred to above,
(b) Applications submitted prior to 28th Dec, 2014, should not have been kept pending from May, 2014 for rejection in this unlawful manner. Keeping the applications pending for months is a fashion in NPPA although for public consumption e-filing etc are shown to be followed. The whole issue merits scrutiny,
(c)In so far as this combinations are concerned no body hold permission from DCGI as the same was not required. All hold the permission from SDC. Permission is of date prior to 1st Oct, 2012 as is clear from above and as such applications should not have been rejected on grounds which have no validity. Further to tell to get the name of marketer endorsed from SDC and then to say that it is not of date prior to 1st Oct, 2012 further shows skeletons being created by NPPA showing that they are acting arbitrarily and in a motivated manner.
(d)In several instances in similar situations approvals of retail price have been granted by manipulating date of endorsement of marketer as logically no endorsement in permissions granted upto 1st Oct, 2012 is possible of future date. When extension of the licences beyond 1st Oct, 2012 are valid there is no reason that endorsements of marketers/manufacturers beyond the said date should not be valid.
6. The issue is why rejections were made and full details may be obtained to know the characters involved and why they took wrong stand and taking money from the companies they changed it as is clear from the meeting of the Body of Experts held on 29th Oct, 2015(agenda item 8). The matter must be investigated. Those who rejected the cases using the authority of Chairman and Member Secretary must be brought to justice if corruption is to be stopped.
7. Under DPCO, 1995, 90% of the prices fixed under Paragraph 9 and 11 were fake and were fixed after collecting money from big companies by officers of the Ministry, Ministers and NPPA officers an before such prices were fixed companies were selling at their own prices and no notices were issued for violation of Paragraph 8(6). Thereafter most of the companies stopped production and consumers had to pay high prices for costly substitutes. Investigating Committee must be set up as NDA Ministers who were given opportunity are sleeping over the issue. There is a massive corruption in this. After seeing this all must be ashamed as to what is going on and has been going on and where the NDA Ministers are. What the Minister has done for make in India should be explained by him instead of recommending a separate Ministry for Drugs and Medical Devices to put this corruption under the carpet.
8. The reasons for routing orders through PSU’s like Rajasthan IDPL and others for drugs required for National Health Programme by Mr Gulam Nabi Azad when he was Health Minister must be investigated as through such orders even when such units never produced orders were routed through them on paper for passing of commission. MD’s of these units be also investigated as besides Minister they were given a share in commission. In this manner crores of Rs. were swindled. Even today money is being swindled on DDT purchased from PSU and Health Ministry is sleeping over invoicing of prices of chemicals required for production of DDT to boost its price. Who is eating the cake now is an issue. Heath Minister should look into all this gamut of corruption in his Ministry.