India: Food & Pharma Flash - June 2014

The proactive step by the Health Ministry is initiating the planning stage for plans for health sector. Further, Kerala government plans to regulate the service rendering systems of private hospitals. In the 13th legislative assembly the Kerala Clinical Establishment (Registration and Regulation) Bill, 2013 ("Bill") was presented for the first time and is yet to get a go-ahead. Meanwhile, it is already facing opposition from various associations and private hospitals who are alleging that the mandates laid out in the Bill are unaffordable. Further, Maharashtra FDA is introducing the online extended licensing node (XLN) system to streamline and speed up the license procurement process in the state.

Health Ministry mulls new plans

The Health Ministry initiated consultation on government action plan for the first 100 days with respect to healthcare reforms. The new health policy has been mulled along with the rural health program, mission mode project for malnutrition, plan for a program for senior citizens and reviewing the existing geriatric care program. Disease Management Association of India anticipates that the plan will also cover the long forgotten issues of telemedicine, mHealth and setting up of National eHealth Authority.

PSA view – Its good that government is showing concerns and proactively initiating the planning stage. The need of the hour is streamlining the whole process in a systematic manner so that healthcare becomes easily accessible to the common man.

Kerala Clinical Establishment Act, 2013 facing the music from private players

The  Kerala government is all set to usher in the Bill. It aims at regulating registration and regulation of clinical establishments rendering services in recognized systems of medicines in the State. However, before the legislative assembly takes it up, the private hospitals, the Qualified Private Medical Practitioners Association ("QPMPA") and various hospital management bodies have already begun to raise objections to the move of the government alleging that it will adversely affect the small and medium size hospitals.

Urging the government to desist from presenting the draft bill in its present form, QPMPA is inviting healthy discussions to effect amendments in the Bill with a view to safeguard interests of small sized health centers. The association feels that once the Bill is notified, it will escalate the cost for the treatments currently meted out to the poor patients by the private establishments. Further, the hospitals have to make facilities for ambulance services, car parking, emergency services and typical infrastructural facilities as specified therein. This will be too difficult for small hospitals to afford and manage. As per the association, many  private hospitals owned by young medical graduates who are giving healthcare services to the poor patients on small rates will be forced to shut down their units owing to compulsory costs to be imposed by the Bill. Having said that, they agree that a control over hospitals is necessary to prevent the infiltration of quacks.

PSA view – Its good that the state government is working on regulating private hospitals, but as government is expected to adhere with the concept of a "welfare state" at all times, the Kerala government too must consider the issues raised by QPMPA. It should appreciate that the opposition isn't for the Bill per se, rather it is with respect to affordability of the mandates that the Bill plans to impose. The State should step in and share the costs or consider a model where it provides for ambulance services, certain infrastructural facilities and ensure that the private players utilize them with utmost efficiency. PSA is of the view that a mid-way approach should be taken in such issues. Once implemented, the move would most definitely be replicated in other states as well.

Maharashtra FDA goes online

Maharashtra FDA has completed the initial stages of implementation of the online extended licensing node (XLN) system at its Thane division under the technical guidance of National Informatics Centre. The XLN system is expected to deliver online approvals for over 15 licenses and 7 certificates required by pharma manufacturing units. Maharashtra FDA with its head office in Mumbai has 43 licensing authority offices stationed in various districts. Some licensing authorities handle more than one district operations. Each licensing authority office is headed by an Assistant Commissioner with four to five drug inspectors or senior drug inspectors. It is also sales and manufacturing license issuing authority and its enforcement activities revolve around monitoring of quality of drugs manufactured or coming from other states. There are 1,703 manufacturing units in the state out of which 247 units are WHO GMP certified. There are 883 allopathic units, 452 ayurvedic units, 31 homoeopathic units and 337 cosmetic product units across the state. Exports of medicines worth INR 155,000 million have been accounted from Maharashtra in the year 2013-14.

PSA view –  This system will help considerably in saving the time and manpower as it will be a centralized and paperless system. As Maharashtra FDA receives over 8,000 applications in a year for manufacturing licenses, it would be prudent for them to introduce this online system across the state. This will assist in accomplishing timely disposal of, among others, the renewal of licenses, testing licenses, licenses for additional products, performance certificate and free sale licenses. 

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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