FOPE, HDMA members meet DGCI, state regulators
The September 21st meet saw productive discussions on the many recent regulatory changes
Federation of Pharma Enterpreneurs (FOPE) and Himachal Drugs Manufacturers Association (HDMA) organised an interactive session with several companies which have manufacturing facilities in Punjab, Haryana, Himachal and Delhi. The event was attended by the state regulators of these states as well as Drug Controller General (India) and Director of the Regional Drugs Testing Laboratory (RDTL) Chandigarh.
More than 12 Dy Drugs Controllers and Assistant Drugs Controllers of various states were also present in the audience, lending to more gravity to the meeting. Responding to the concerns raised by industry representatives, the regulators tried to allay their fears and shared their insights on the industry’s future.
More than 275 delegates from four states (HP, Haryana, Punjab, Delhi and Uttarakhand) attended the joint meeting, at similar sessions. This time, four states regulators i.e. Punjab, Haryana, Himachal and Delhi were on the dais along with DCGI and Director of Central Laboratory.
FOPE’s lists its concerns
BR Sikri, President, FOPE stated in his welcome address that he sees great potential for the pharma industry inspite of regulatory changes and frequent intervention by the regulators. He also highlighted that the government of India has kept a provision to increase its healthcare spend from 1 per cent to 2.5 per cent by 2025. Public health is also being prioritised by the government. Sikri also mentioned that while the demand from the rural markets is 65 per cent, the industry is only meeting 17 per cent of this demand. But government is trying to make amends for it by strenghtening the Jan Aushadhi project. He also elaborated on the growth drivers of the industry such as rise in disposable incomes of the common man, a rapidly ageing population which will add to the need for healthcare, the shift of products to the OTC segment and more medicines coming off patents. Also many states are coming together to form mega pharma parks and there will be more focus on contract research along with improving manufacturing services capabilities.
Sikri also expressed concerns on the challenges faced by the industry. Due to lower spendings on R&D and constant regulatory interventions, productivity is going down. Infrastructure like cold chain and supply chain networks are weak and therefore he stressed that it is high time these factors are improved as these can further enhance the effectiveness of the distribution process.
Sikri also appreciated the various initiatives taken by CDSCO in the recent past, for instance, launch of the e-portal Sugam, emphasising the importance of pharmacovigilance and maintaining transparency in the work culture. Some other measures he highlighted were setting up of public relation centres and intelligence cells by DCGI at the CDSCO main office, which has strenghthened the ties between companies and consumers as well as made CDSCO officers more easily accessible to industry.
HDMA too highlights pending issues
Rajesh Gupta, President of the HDMA raised the matter of Guidelines of 33 P issued under Drugs and Cosmetic Act. He informed that a joint representation was given by HDMA and FOPE to the Health minister five months ago and requested for the creation of the Pharma Association Forum, convert guidelines under 33 P into Rules and allow MSME nominee to be a part of DTAB.
He also informed that the Minister accepted all the three requests of the industry. The forum was created and is currently operational. However the other two major issues of Guidelines and MSME nominee to be on the Board of DTAB are still pending. Gupta concluded by mentioning that the DCGI was requested to intervene in the matter and expedite the two pending issues.
Vinod Kalani, Co Chairman and Aprjita, General Secretary of FOPE raised certain issues on behalf of the industry. They spoke about the constant changes in rules especially with respect to changes in labelling requirements. They suggested that this can be addressed if the Ministry of Health & Family Welfare forms a group of experts to conduct an impact analysis before a notification is issued which will change the Act & Rules. This will give more clarity on the reason for the proposed change in the rules. This can accordingly be applied in a uniform manner across the country. They suggested that in view of a change in the rules, a guidance document may be issued for the industry for clarity in the matter.
Speaking about the DAVA portal, which requires manufacturers to upload data pertaining to licenses and products manufactured, they said that certain apprehensions need to be addressed like the secrecy around data, ,non-availability of a dedicated portal and harassment. They pointed out that as the data is already available with state licensing authorities (SLAs) who are responsible for the grant of licenses, the same can be obtained from them.
Apart from these concerns, the experts emphasised on the importance of extending the validity period of COPP to three years from two years to avoid any delay in execution of export orders. Even the licenses for the manufactured FDCs cleared by Prof Kokate Committee may be issued by SLAs instead of CDSCO as per present practice. In a similar vein, they suggested that cases should be filed in states where drugs have been manufactured rather than from the states where the samples have been collected for testing.
Speaking about BA / BE studies, they pointed out that the ambiguity in the notification, regarding applicability for solid oral dosage form and not oral dosage form as stated in the notification, is yet to be addressed. On e-pharmacies, the experts mentioned the grey areas in the draft rules which need to be plugged . If not effectively implemented, they pointed out that e-pharmacies may aggravate the problem of antibiotic resistance and also lead to misuse of ND&PS and thirdly, without a data base of registered medical practitioners (RMPs), it may be difficult to check on fake prescriptions. Another suggestion they made was that joint inspections should not be made compulsory and should be carried out where quality concerns are apprehended.
On PIC/S, the view expressed at the Panchkula meeting was that instead of India becoming a signatory to PIC/s, the country should have a uniform and harmonised system of good manufacturing practices by making suitable changes in the existing Schedule M.
Response from DCGI
Dr S Eswara Reddy, DCGI highlighted the steps taken for simplification of procedures for the sake of ease of doing business such as simplification in clearance export and import consignments at ports, NOC for export of unapproved drugs, establishment of facilitation centre at CDSCO (HQ) and a transparent way of working at the HQ and Zonal levels etc. A committee should be made for analysing the impact of the proposed changes in the Act and Rules. The DCGI declined to comment on the FDC matter as it was subjudice.
While addressing concerns on the DAWA portal, DCGI stated that the portal is at an advanced stage of readiness and this will help create a data base of manufacturers and products, which would help weed out unscrupulous / clandestine manufacturers. He assured the gathering that complete secrecy of the uploaded data would be maintained. He further advised manufacturers to critically examine their licenses and weed out and surrender the licenses for unwanted formulations.
Responding to the request for uniform implementation of rules, the DCGI drew the attention of the gathering to the circular regarding SLAs and expected all SLAS tp follow the directive of the Ministry. Addressing the concerns on e-pharmacy, he mentioned that the draft rules will be examined
based on suggestions received from the public. E-Pharmacy will benefit patients who will get medicines from manufacturers or distributors at discounted prices.
… and state regulators
Navneet Marwaha, State Drugs Controller, HP stated that before a notification is issued, pros and cons must be examined along with difficulties in implementation, steps should be taken for uniform implementation of rules and regulations by all the states, disparity existing now in grant of licenses for new drugs should be eliminated. He went on to mention how his office is strictly following the procedure for grant of licenses for new drugs and is collecting monthly data for 13 drugs. He was of the view that that the award of tenders on the basis of L-1 requires reconsideration and that quality should be the prime consideration.
NK Ahuja, Drugs Controller, Haryana spoke on how weeding out of irrational FDCs is essential for retaining the image of the industry. He was of the view that PIC/S will result in a harmonised and uniform quality system. This will need up gradation of inspection systems of the regulatory authority, will reduce documentation and inspections for export to PIC/S country. He stated that the e-Pharmacy draft notification has several deficiencies and grey areas which are to be plugged and that he will take up all similar issues with the ministry.
He mentioned that the proposal for data loading on SUGAM has several hurdles if seen from a legal point of view and should be kept in abeyance. His view was that the entity marketing the drug should be made liable for quality of the drug. As there were very few centres for BA / BE studies, more time should be given for implementation of the same. Concluding his talk, he said that all the provisions of the joint inspection should be welcomed by the industry.
Pradeep Mattu, State Drugs Controller, Punjab stated that the industry should implement the Quality by Design process which will assure the quality of drugs being manufactured.
Dr Ram Avtar Singh, Director, Regional Drugs Testing Laboratory (RDTL), Chandigarh stated that many manufacturers fail to make the placebo and other details for testing samples available to them. He has also noted that manufacturers of formulations do not test APIs before use, which results in formulations failing the test due to substandard APIs. He therefore stressed on the quality by testing and advised testing of API for related substances and impurity profile before use. This would bring down number of NSQ samples.
In his vote of thanks, Rajesh Gupta, President, HDMA requested DCGI that while the government puts NSQ data in the public domain, it is important to also publish data of standard quality (SQ) so that the public at large understands the comparasion between NSQ and SQ.
The meeting thus saw a very productive interaction between industry stakeholders and the regulatory authorities, with the former getting some of their concerns addressed and regulators agreeing to follow up on pending matters.