Review of the policy on Foreign Direct Investment in Pharmaceutical Sector – carve out for medical devices

Review of the policy on Foreign Direct Investment in Pharmaceutical Sector – carve out for medical devices 

The Union Cabinet chaired by the Prime Minister, Shri Narendra Modi, today gave its approval to amend the existing Foreign Direct Investment (FDI) policy in the Pharmaceutical Sector to create carve out for medical devices.

 As per the extant FDI policy for pharmaceuticals sector, FDI up to 100% is permitted subject to specified conditions. While FDI for green-field projects is under automatic route, brown-field projects are placed under government route. The Policy on the pharmaceutical sector covers `medical devices` since this area is not separately covered.

 Since medical devices are part of the Drugs & Cosmetics Act, 1940 and fall under the Pharmaceutical sector, all the conditions of the FDI policy on the sector, including the condition relating to `non-compete clause`, apply on brownfield investment proposals of medical devices industry. As per National Industrial Classification (NIC) Code 2008, sector code of `Manufacture of pharmaceuticals, medicinal chemical, and botanical products` is 2100 while sector code of `Manufacture of medical and dental instruments and supplies` is 3250. Medical devices will fall under the category of `medical and dental instruments and supplies`. Therefore, drugs and pharmaceuticals and medical devices are two different industrial activities. The condition of `non-compete` was imposed so that the Indian manufacturers can continue manufacturing generic drugs and catering to the needs of the large number of people in the country and in other developing countries who cannot afford branded and patented drugs. This condition is not relevant to `medical devices` industry of the country where the country is substantially import dependent and the sector is adversely impacted because of the lack of adequate capital and required technology.

Therefore, the Cabinet approved the following proposal to amend the relevant paragraphs of the extant FDI policy as contained in the Consolidated FDI Policy Circular 2014 as follows:

         i.            FDI up to 100%, under the automatic route is permitted for manufacturing of medical devices. The abovementioned conditions will, therefore, not be applicable to greenfield as well as brownfield projects of this industry.

       ii.            Medical device means-
a. "any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes of-
(aa) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ab) diagnosis, monitoring, treatment, alleviation of, or assistance for, any injury or handicap;
(ac) investigation, replacement or modification or support of the anatomy or of a physiological process;
(ad) supporting or sustaining life;
 (ae) disinfection of medical devices;
(af) control of conception,
and   which does not achieve its primary intended action in or on the human body or animals by any pharmacological or immunological or metabolic means, but which may be assisted in its intended function by  such means;

b. an accessory to such an instrument, apparatus, appliance, material or other article;
c. a device which is reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system whether used alone or in combination thereof intended to be used for examination and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body or animals;

iii     The definition of medical device at Note (ii) above would be subject to the amendment in Drugs and Cosmetics Act.

India has achieved an eminent global position in pharma sector. However, same has not been replicated in the medical devices industry. The country has huge pool of scientists and engineers who have potential to take medical device industry to a very high level. Domestic capital market is not able to provide much needed investment in the sector. Easing of norms for medical devices industry by creating special carve out in the extant FDI policy on pharma sector will encourage FDI inflows in this area.

Stamp on “Kuka Movement” Released 

Union Minister for Communication & IT, Shri Ravi Shankar Prasad here today released a commemorative stamp to highlight heroic deeds of those engaged in Kuka Movement. Speaking in the occasion, Sh. Prasad said that the sacrifices made by people of Punjab will be always remembered. He said members of the Movement raised voice against foreign rule at a time when people feared most barbaric approach of the rulers. The Kuka Movement evolved feeling of self respect & sacrifice for the country. They played significant role in the historic Non-cooperation Movement of India. 

The Kuka Movement marked the first major reaction of the people in the Punjab to the new political order initiated by the British after 1849. The Namdhari Movement, of which the Kuka Movement was the most important phase, aimed at overthrowing the British rule. The Namdharis were also known as “Kukas” because of their trademark style of reciting the “Gurbani” (Sayings/Teachings of the Guru). This style was in a high-pitched voice called “Kook” in Punjabi. Thus, the Namdharis were also called “Kukas”. 

Satguru Ram Singh, son of a poor carpenter, who was born on 3rd February, 1816 in a small village of Bhaini, around 7 kilometres away from Ludhiana, founded the Namdhari Sect on 12th April, 1857 at Bhaini Sahib. He asked his followers to boycott everything which bore the stamp of the British Government. In course of time, Baba Ram Singh became a secular chief of Kukas. He would go about surrounded by horsemen and held his court every day. He appointed Governors and Deputy Governors to organize Kukas in different districts of the Punjab. He also inspired young men by giving them military training. 

The Kuka Movement made the people aware of their serfdom and bondage. It evoked the feelings of self respect and sacrifice for the country. Within a few years, the followers of the Kuka Movement increased manifold. They called for boycott of educational institutions of British and laws established by them. They were rigid in their clothing and wore only hand-spun white attire. The Kuka followers actively propagated the civil disobedience. 
‘Digital India’ is to be A Game Changer for the Country 

Electronics Manufacturing to be Given Major Boost 

Communications-Call to all 

New Goal Posts set for the Postal Department 

Year End Review 2014

One of the India’s core strength the Information Technology is sought to be taken to new heights. Midway through the year the new Government came in and shifted gears to fast track usage of all technologies including the Information Technology. The Digital India is to be an overarching Programme for empowering people. E-governance is to be hallmark for good governance. Steps have been initiated to connect over 2.5 lakh Gram Panchayats by laying about 7 lakh kilometers of optical fiber cable in the next three years. Over 1,13,000 crore rupees is expected to be spent on the programme over next 5 years.

Launching the National Digital Literacy Mission in August this year, the Prime Minister had said that a digital revolution was about to begin. Modi went on to say that his vision of a `digital` India encompasses a time when the common man is able to track the government`s work from his mobile phone.  There is the Digital Saksarat Abhiyaan (DISA) to make 42.5 lakh people digitally literate. A scheme for the purpose was approved on 9.12.14 under Digital India. Out of the total target, 4 lakh candidates are to be trained by Industry, NGOs and others through their own resources/under CSR and remaining 38.5 lakh candidates would be supported by Government.

Various applications of IT have started to be introduced. Jeevan Pramaan is one such application for biometric identification system for pensioners and biometric attendance for government employees. The Jeevan Praman was also launched by the Prime Minister indicating the importance that the Government is giving to the sector.
The minister for Communications & Information Technology Shri. Ravi Shankar Prasad stating some details relating to his ministry. (Courtesy: Doordarshan News)
Another area that a new focus was laid was Electronic manufacturing. Electronics Manufacturing Clusters (EMC) Scheme now provides financial assistance for creating world-class infrastructure for electronics manufacturing units and Modified Special Incentive Package Scheme (M-SIPS) provides financial incentives to offset disability and attract investments in the manufacturing of electronics products (including telecom).  Electronic Development Fund to promote Electronic System Design and Manufacturing (ESDM)has been set up Promotion of Electronic Manufacturing Clusters: foundation stone laid at Bhopal and Jabalpur. In principle approval given to 16 more clusters. Giving importance to the skill development in Electronic System Design and Manufacturing (ESDM) sector, the Prime Minister again took time to lay foundation stone for National Institute for Electronics & Information Technology (NIELIT) center Ranchi.

Again at the initiative of the Prime Minister a High Level Task Force headed by the former Cabinet Secretary Shri T.S.R. Subramaniam was constituted to propose for revitalization of the Department of Posts. As a part of the modernization of the Department Selection of vendor for supply of hardware connectivity and services to about 1,30,000 rural post offices has been completed and Letter of Intent (LoI) issued to the selected bidder.

Most other developments in the Department through the year are as illustrated below:-
As the communications forms the basis for the Information Technology, there have been efforts to strengthen the sector through allocation of more spectrums to the Telecommunication operators. Public WiFi hotspots in universities and public places are sought to be installed.

Some of the details relating to Telecommunications are :-
The Minister for Communications & Information Technology as a part of the Good Governance Day tomorrow is to launch among others the following new initiatives of his Ministry:- . The invitation for the same is:-

1.      Gyansetu- internet based real time ICT system to provide e-services to be launched on 25th December, 2014.

2.      Jodi Plan for Mobile for MTNL Subscribers to be launched on 25.12.2014

3.      One month rental free for broadband and broadband & landline combo plans for new bookings for MTNL customers on 25.12.2014.

4.      Launch of Time Stamping of CCA - Time stamps establish the time when a document or transaction was created. The service has been created and is ready to be launched by three Certifying Authorities (CA) – (n) Code Solutions, eMudhra and SIFY.

5.      Launch of Good Governance Booklet: As indicated by a note received from Cabinet Secretariat, this booklet will highlight key achievements of DeitY and will act as a ready reckoner for general public. The booklet will be published in both physical form and e-Book. The draft list of the items to be included in the book has been prepared

6.      Short Audio Visual (Film)- The proposed AV/Film will highlight the key achievements of DeitY. The proposed length of the film is 8-10 mins and the key projects taken up by DeitY namely MyGov, Biometric Attendance, Revamping of MMPs, Digital Locker, e-Book & e-Bhasha platforms, Jeevan Praman, e-Sampark and Mobile Seva.

7.      e-Book platform developed by CDAC – Developed by CDAC, the e-Book platform will allaow all Govt Dept/agencies to create e-Books in standardized format. This will allow the general public to have cost effective access to large amount of educational material and Govt reports/Publications in digital formats.

8.      e- Governance Competency Framework :- Competency based selection for implementation of e-governance would also support good governance. Developed by DeitY, this framework assesses and enhances the competencies of Government officers for visualizing, conceiving and delivering projects aimed at transforming existing systems. eGCF will make the e-Gov services in the country more sustainable and responsive to the needs of citizens.

9.      Chips to Institutions/Systems Project :- The project aims at developing skilled/specialized manpower in areas of micro electronics, VLSI, Systems development on Chip, through premiere institutions like IITs and IISCs etc. It will result in development of more than 50,000 industry ready professional will be produced.

10.  NIXI project (Gujarati idn) :- An initiative of the Internet Governance Division of DeitY to ensure inclusive development using the Internet. The local language plays a critical role in making Internet more inclusive by widening the knowledge base across communities in the native language and promoting the use of local language content. The growth of Internet has mainly taken place in one language namely English leading to the language barriers for non-English speakers. . भारत Country Code Top Level Domain Name (ccTLD) in Devanagari script was formally launched by the Hon’ble Minister for Communications and Information Technology, Mr. Ravi Shankar Prasad on 27 August, 2014. After the launch of .Bharat in Devanagari script National Internet Exchange of India (NIXI) jointly with C-DAC propose to launch the IDNs in Gujarati, Bengali and Manipuri on Good Governance Day on December 25th, 2014.

11.  Mobile as Digital Identity: - DeitY conducted a consultation workshop in October 2014 to brainstorm on various aspects of how mobile phones can be used as instruments for electronic authentication of individuals’ identities. The participants included industry practitioners/ bodies, members of the academia, implementers, regulatory authorities, and officials from DeitY and other departments. The key outcome of the workshop and further deliberations was that “digital identity” should imply enabling mobility while establishing a person’s identity. For usage of mobile as an instrument of digital identity, three possible mobile identity solutions emerged: (1) mobile number linked with Aadhaar; (2) mobile digital signatures; and (3) voice biometrics (either standalone, or linked to mobile number). Work is underway to implement the most efficient and effective solution to enable citizens to enjoy the benefits of a mobile cradle-to-grave digital identity. A report on “Mobile as Digital Identity” is proposed to be launched on 25th December 2014.

12.  NGN (Next Generation Network)Switch of BSNL, DoT:- BSNL will able to offer new services after NGN like Wide Area IP Centrex (WIPC), Multimedia services (MMVC), Prepaid which are not available on TDM switches. It enables to offer Multimedia communication with Quality of Services (QoS). The service will be launched through a Video phone facility between Delhi & Bangalore.


End-to-end Computerisation of PDS- A step towards good Governance 

Ministry of Consumer Affair, Food and Public Distribution is implementing a Plan Scheme on End-to-end Computerisation of TPDS Operations on cost sharing basis with the States/UTs. The scheme has been declared as a Mission Mode Project (MMP) by the Government.

The Scheme comprises following activities and expected outcomes:
·        Digitization of TPDS (Targeted Public Distribution System) related data- Correct identification of beneficiaries: removal of bogus cards: better targeting of food subsidy.
·        Computerisation of Supply Chain- Timely availability of foodgrains at FPS (Fair Price Shop): check leakages/ diversion.
·        Grievance Redressal Mechanism and Transparency Portal- Bring transparency & Public accountability.
·        FPS automation- Ensuring that correct beneficiary receives the entitled quantity of foodgrains.

 On fully implemented, the Scheme will provide various citizen centric services as given below:

·          Ration card related requests such as application for new ration card, change of address, name change, deletion of member, etc. can be dealt online through the system. This will provide beneficiaries a convenient facility and minimise their visit to Food & Civil Supplies offices.

·             The digitised list of beneficiaries shall be made available in the public domain on State Governments` TPDS portals. This will introduce transparency in the identification of beneficiaries, allow beneficiaries to check their status, encourage social audit etc.

·             Through the State TPDS portal, beneficiaries can also check status of foodgrains allocated for their respective Fair Price Shop (FPS) each month including quantity delivered at the FPS, when delivered etc. Beneficiaries can also enrol for SMS alert facility, so that they are informed on mobile phones through SMS about despatch of vehicle carrying foodgrains, receipt at the FPS, etc. Timely access to information relating to availability of foodgrains will prevent denial of entitlement to beneficiaries, reduce their trips to FPSs etc.

·             The facility for registration of grievances and tracking their status is also available through the State TPDS portal, toll-free helpline numbers, etc. If the complaints are not responded in time, the same would be escalated to senior officers for timely redressal. Under the integrated module for grievance handling, if beneficiaries provide mobile numbers while filing their grievances, through SMS they can receive its acknowledgement and once the grievance is settled, they can again be informed.

(v)        Computerisation of last mile activities i.e. distribution of foodgrains at the FPS level is also being taken up. Once automation of FPS is implemented, the genuine beneficiaries can be authenticated through point of sale device at FPS, the sale transaction captured online etc. so as to ensure that the entitled quantities of foodgrains reach the actual beneficiaries.

National Informatics Centre (NIC) is the technical partner under the scheme and has developed a Common Application Software (CAS) as per the scheme requirements, which has been offered to States/UTs.

Ministry of Consumer Affairs & Food to have all official work on E-Files within three months 

Ram Vilas Paswan discuss best governance practices with officials on the eve of Good Governance Day 

Ministry of Consumer Affairs, Food & Public Distribution has decided to have all official work on E-Files. Initiative in this regard has been taken and within next three months all proposals will be put up and approvals will be taken on e- files only. This was decided in a meeting chaired by Shri Ram Villas Paswan, Minister of Consumer Affairs, Food and Pubic Distribution to discuss best governance practices here today on the eve of “Good Governance Day”. The Ministry has also decided to review public grievances disposal mechanism to further increase the disposal rate which is 89 percent at the moment. 

Addressing the officials of his Ministry, Shri Ram Villas Paswan retirated the Government’s Commitment for Good Governance in every sphere of its working. He said that disposal of official work should be time bound and directed both the Secretaries of his Ministry to draw time frame for his purpose. He said that policies should be public interest oriented and officials should be sensitive towards welfare of the common man. 

On the occasion the Minister also received the progress of end to end computerization of PDS being implementing across the country with the financial assistance from the centre besides review of consumer empowerment provisions. 

Maiden Flight of Panchi 

Panchi, the wheeled version of Unmanned Aerial Vehicle (UAV)Nishant capable of taking-off and landing using small airstrips had its maiden flight lasting about 20 minutes. Today’s flight was preceded by a series of high speed taxi trials. SA to RM, Secretary. Department of Defence R&D & DG DRDO DrAvinashChander, congratulated the team for the success. The UAV Panchi has all the surveillance capabilities of UAV Nishant. However, it will have longer endurance as it does not have to carry the air bags and parachute system as in the case of UAV Nishant. DS and DG Aeronautical SystemsDr K Tamilmani said, “Aggressive efforts by the ADE (Aeronautical Development Establishment) team during the past 8 months in creating this version are commendable”. 

The conventional NishantUAV already inducted in Army is a multi-mission UAV with Day/Night operational capability, launched from an all-terrain hydro-pneumatic launcher and is recovered with the help of on board parachute system and an underbelly airbag. It is designed for battlefield surveillance and reconnaissance, target tracking& localization, and artillery fire correction. The electro-optic payloads are mounted on a stabilized steerable platform. A sophisticated image processing system is used for analyzing the images transmitted from the UAV. The aircraft has a jam resistant command link and digital down link for transmission of imagery. The air vehicle has autonomous flight capabilities and is controlled from a user friendly Ground Control Station. 
Review of the policy on Foreign Direct Investment in Pharmaceutical Sector – carve out for medical devices Review of the policy on Foreign Direct Investment in Pharmaceutical Sector – carve out for medical devices Reviewed by Ajit Kumar on 6:01 PM Rating: 5

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