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Advancement in the date for implementation of revised schedule M: -

As you know that in 2003, our Central Government made draft rules for revising the already difficult schedule M. This planned revision of the schedule M was so stringent that it was not possible to fulfill all its different parameters by our small scale units. To meet its difficult conditions it entailed very heavy investment on every company’s part. However with the dedicated intervention of CIPI we succeeded in getting its execution date extended twice and was also able to dilute the severity of its many features. This has greatly reduced the fear of schedule M amongst our manufacturers. Thanks to these tireless efforts, most of us were spared a harsh future with only a few firms having very poor infrastructure being forced to close their plants. Today more than 90% of the industry survives and thrives thanks to the great work done by CIPI a fact that is well recognized among all our members and also the Government. I vividly remember the day of year 2004 how Smt. Sushma Swaraj, the then Hon’ble Health Minister came especially to her office only to sign the extension date of the implementation of revised Schedule ‘M’. I was fortunate to be present on that occasion in the Hon’ble Health Minister’s office at Nirman Bhawan.


-    Enhancing investment limit in plant and machinery to be recognized as a small and medium scale unit: -

Dear members you are aware that earlier this limit for our small scale units was only one crore and this was highly insufficient given the competitive nature of our industry and the need to invest in specialized machinery, ongoing R&D investments and to adhere to different schedule M requirements. Hence with our ongoing efforts, we were successfully able to impress upon the government to raise this investment limit up to a reasonable level Rupees 5 crores. Additionally we were also able to enhance the list of plant and machinery to be covered under units’ purview to cover almost all its plant and machinery including the air conditioning system.


-    Getting relief for the Industry form the Madras High Court concerning 294 FDC’s order of DCGI:

As you will recall that difficult day when acting in a highly arbitrary fashion the Drugs Controller General of India banned 294 FDC’s by simply issuing a terse letter addressed to different SDCs at state level. And this was not all as there were several other drug formulations under scrutiny to be banned in the near future. This had the entire Industry very worried as the sudden banning of 294 FDC Drugs hurt us all badly. In an urgent CIPI meeting at Delhi it was decided that immediate action should be taken in this regard and we decided that we must take the help of our legal system. We thus approached Madras High Court for grant of interim relief. At the same time our General Secretary Mr. B. Sethuraman and Chairman Mr. Jai Shankar were already using their good offices and professional connections to build a case to protect our industry interests. On my arrival in Madras we all worked tirelessly with our eminent lawyers and industry leaders to get a stay order on this arbitrary law which we won in just one day of our filing of the writ petition thanks to all the great work done by CIPI. It was a great victory for the entire industry and our great nation has benefitted immediately and immensely. I take great pride in sharing the fact that this stay order is still in force and protecting our valid interests. We must thankful to Mr. B. Sethuraman, our General Secretary who taken a lot of pain to get this stay order.


-    Getting stay from Madras High Court in COPP matter: -

Members are aware of an another unilateral decision that was made by DCGI insisting all units to get a COPP issued in their favour in order to qualify for undertaking exports. This highly bureaucratic procedure was forced upon us all by the office of DCGI without consulting the industry. As the Pharma Industry is today spread across different parts of the country it is not feasible for everyone to get COPP from Delhi based office of the DCGI as the distance for many firms is considerable. Again CIPI successfully intervened in this urgent matter and approached Madras High Court to get a stay order on this unilateral and unjustified action of DCGI for insisting on the issue of COPP for allowing units to export. Again we were successful in getting a stay order from Madras High Court. Simultaneously, on this issue, stay order was also granted by Karnataka High Court in favour of Pharmaceutical manufacturers maintaining status que. Now State Drugs Controller throughout the country are in power to issue COPP.


-    Obtaining stay from the Madras High Court on the order of the Ministry of Health and Family Welfare concerning Nimesulide and Phenylpropanolamine HCl: -

In another unilateral decision, the Ministry of Health and Family Welfare suddenly issued a terse letter banning preparation and sale of Nimesulide & Phenylpropanolamine HCl without even bothering to consult with the industry. This arbitrary act imposed great hardships on our member units as we were not given any time to liquidate the stocks lying in our godowns. This translated to a huge loss amounting to many lacs of rupees for our industry. In a swift and corrective manner CIPI joined hands with IDMA and successfully got a stay order from the Madras High Court. Today the pharma industry is free to do business as usual and is able to legally sell these important formulations.


-    Obtaining stay order on DGFT order requiring bar coding on secondary and primary packing of medicines :

In another shocking order of DGFT completely destroyed our pharma sectors’ exports potential. This order of DGFT on the requirement of putting bar codes on all product packaging was so complex that it was not possible for our SSI units to implement it as it required huge investments to the tune of at least Rs. 10-20 Lacs by every firm. Small Scale Industry was very worried about the implementation of this arbitrary order and in these circumstances we again decided to approach Madras High Court to get a stay order for relief. It is a matter of great honour for CIPI as the stay was promptly granted by Madras High Court.  It is also another achievement of Mr. B. Sethuraman, our General Secretary, we are debited to him. However Ministry of Commerce approached Madras High Court and requested to Hon’ble Judge that now sufficient time has been provided to pharma manufacturers, in view of this Madras High Court suspended the Stay Order. Now the exporters are putting Bar Code on the secondary and tertiary packing. In respect of barcode on primary packaging, on our request Ministry has extended to implement barcode on primary packaging from July 2014. On the other hand, Ministry of Commerce issued a public notice dated 17th October 2013 & clear that mono cartons containing strips/vials/bottles be treated as Primary Level Packaging.


-    Obtaining Stay Order on the issue of Safety & Efficacy for all FDC from Punjab & Haryana High Court and Himachal Pradesh High Court, Shimla

DCGI issued a letter dated 15 Jan 2013 to all SDCs/UTs directed them to convey the manufacturer units of their states for approval of safety and efficacy of FDC which was permitted for sale by SLA/SDC in the country without due approval from office of DCGI.

Further, in this regard, a notice was issued by DCGI on 1st July 2013 and letter dated 5th July 2013 given the procedure which should be followed for filing the application for assessing the safety and efficacy of FDCs:

1.    The concerned manufacturer(s) shall apply in form 44 along with requisite Treasury Challan and supporting documents supporting the safety and efficacy of the FDC.

2.     The applications will be examined in consulation with Expert Committee. If considered necessary, the applicant may be asked to present their case before the committee.

3.     In case of requirement of clinical trial, protocols etc., should be submitted the firm for approval by DCGI.

4.     In case of multiple application for the same FDC, all such applicants will have option to conduct one such study (wherever necessary) sponsored by the firm(s), if required.

Another letter was issued by DCGI on dated 26th August 2013 addressed to SDC/UT asked to manufacturer to submit the application either in CDSCO HQ or respective zonal/sub-zonal offices of CDSCO under whose jurisdiction manufacturers are located.

Another letter was issued by DCGI on 2nd September 2013 addressed to all SDC and directed them to ask the manufacturers to submit their application in form 44 along with requisition fees and supporting documents latest by 30th September 2013 and also indicate in case the applications of FDCs are not submitted by the manufacturers by 30 Sept 2013, it will be presumed that they are not willing to prove the safety and efficacy of such FDCs before the office of DCGI.

Another letter was issued by DCGI on 3 Feb 2014 to ask the manufactures who have applied for safety and efficacy of FDC to submit additional documents which are not submitted with their application.

Another letter issued by DCGI dated 28 March 2014 to all SDCs to direct the manufacturers to file their application in the office of DCGI and to make presentation before the office of DCGI, such presentation shall mandatorily contain following information :

1.     Name of product with composition and indication.

2.     Rationale

3.    Pharmacokinetic/ Pharmacodynamic interactions and pharmacokinetic rationality (with half life details of individual drugs, dosage schedule of individual drug alongwith reference etc.)

4.     Published data regarding safety and efficacy of applied FDC.

5.     Original data generated by the applicant on applied FDC, if any.

6.     PMS data generated by the applicant on applied FDC, if any.

7.     Regulatory status of FDC in other countries, if any.

8.     Similar FDC approved, if any by DCGI.

9.     Further studies planned, if any.


It was hard time for SSI to get approval of FDCs in respect of Safety and Efficacy by paying Rs. 15,000/- per product, later on DCGI can ask to the manufacturers who have given application for further additional documents, Bioequivalence & many more informations. Total cost for one FDC can be around Rs. 15 to 20 Lacs which is not possible for SSI. Immediately, our associate association i.e. Haryana Pharmaceutical Manufacturers Association and Sirmour Pharma Manufacturers Association knock the door of Punjab & Haryana High Court, Chandigarh and Himachal Pradesh High Court, Shimla and got Stay Order against all letter mentioned above issued by DCGI to SLA/UT till the final decision of High court, there is no need to put application in office of DCGI. It is great achievement of CIPI associate associations, however if any manufacturer wants to clear FDC products, he can apply to the DCGI office at Delhi.

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