Maharashtra’s FDA Orders Filing Of FIRs Against Snapdeal, Its CEO Kunal Bahl, Directors And Distributors For Online Sale Of Prescription Drugs

Maharashtra’s FDA Orders Filing Of FIRs Against Snapdeal, Its CEO Kunal Bahl, Directors And Distributors For Online Sale Of Prescription DrugsIndian government has been very lax regarding regulating e-commerce functions in India. Although there is dire need for e-commerce laws in India yet Indian government has failed to address this crucial requirement. There were also some speculations that Telecom Regulatory Authority of India (TRAI) would regulate e-commerce in India.  However, till now there are no sign that Indian government would properly regulate this much needed field.

One area that is grossly neglected by Indian government pertains to regulation of online pharmacies in India that are openly ignoring the regulatory compliances in India. We at Perry4Law believe that online pharmacies laws are urgently needed in India. Even there is no synergy between Digital India, online pharmacies and healthcare laws of India.

A dominant majority of the online pharmacies functioning in India are being run in an illegal and unregulated manner. Many of such online pharmacies are already under regulatory scanner. FDA Maharashtra has recently raided 27 online pharmacies located in Mumbai. Maharashtra FDA has also approached DCGI for regulating illegal online pharmacies operating in India. Surprisingly, many online pharmacies websites in India are controlled by underworld and organised criminal networks. We at Perry4Law have been consistently suggesting that illegal online pharmacies and healthcare websites in India need to be curbed urgently.

In a recent move, the Maharashtra’s Food and Drug Administration (FDA) has ordered filing of FIRs against as well as against its CEO Kunal Bahl, directors and distributors for online sale of prescription drugs in derogation of Indian laws. FDA Commissioner Harshadeep Kamble said investigations into other e-commerce giants like Flipkart and Amazon are also under progress to ascertain if they are also involved in such sales. As on date most of the e-commerce portals are selling prescribed drugs in an illegal and unauthorised manner.

Meanwhile Snapdeal has claimed that it is assisting the FDA team in this investigation. Snapdeal has also informed that it has already delisted the products and said sellers and also stopped payment. However, this does not absolve Snapdeal of its legal obligations and liabilities under various healthcare laws of India. Further, Snapdeal has also failed to observe cyber law due diligence (PDF) that is very common in India these days.

“Jasper Infotech Pvt Ltd, through offered for sale, exhibited for sale Vigora Tablets 100, a drug containing Sildenafil citrate, to be sold on the prescription of a registered medical practitioner – specialist endocrinologist, venerologist, psychiatrist, dermatologist,” Kamble said. The drug was sold by “Mittal Pharma, Kota, Rajasthan, a seller in agreement with Jasper Ascoril Expectorant”, without prescription, he said. “The drug was also sold by Rishabh Enterprises, New Delhi, a seller in agreement with Jasper, to a customer Amrut Bhagat of Panvel in Maharashtra’s Raigad district through a courier in agreement with Jasper, who collected the cost of drug for Jasper,” he said. The officer said Jasper Infotech through exhibited and offered for sale UNWANTED-72 sold by Horizon Medicals, Bangalore, and I-pill, sold by Giriraj Pharmacy in Gujarat’s Gandhinagar, sellers in agreement with Jasper.

FDA has filed an FIR against the persons concerned with Panvel police station, he said. FDA has also sent letters to State Drugs Controllers for action against the concerned people in their states, Kamble said. The contraventions include sale of drug without licence – Sections 18 (c), 18A, rw rules 65 (3), 65(11), 65(17) punishable under Section 27(b)(ii), 27(d) of Drugs and Cosmetics Act, 1940; and Sections 3 and 4 of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. If proven guilty, the offence carries imprisonment of 3 to 5 years with fine of not less than Rs 1 lakh, he added.

A special investigation team was formed to look into the issue of violation by Snapdeal, Kamble added. The godowns of the company were searched on April 16 and 20, he added. It was revealed that Jasper Infotech entered into agreements with different dealers of medicines located all over India to supply the medicines offered/exhibited for sale on and to collect the sale proceeds by Snapdeal on their behalf, the officer said. It was found that the e-commerce major displayed and offered for sale about 45 drugs with objectionable claims which contravenes the provisions of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

“Despite written commitment, it was found that Snapdeal continued to offer, exhibit for sale and sale of drugs, namely, I-pill and ‘Unwanted 72′, emergency contraceptive drugs, through its website,” he said. Kamble said he had asked the FDA team to purchase the drugs online and accordingly drugs I-pill and Unwanted 72 were received on April 24. “Only a licensed retailer can offer for the sale of Schedule H drugs, and that too only on the basis of prescription of doctor. Such type of online sale of drugs is not allowed as per the Act,” the FDA chief said.

Online Pharmacies Laws Are Urgently Needed In India: Perry4Law

Online Pharmacies Laws Are Urgently Needed In India Perry4LawOnline pharmacies are double edge swords. On the one hand they are beneficial to the masses as they provide easy and affordable medicines to the patients and those who are in need of them. On the other hand they are potential source of spurious and dangerous substances passed as medicines that could prove fatal in many cases.

Recently Indian government has launched technology driven projects and initiatives like Digital India, Internet of Things (IoT) (PDF), etc. The aim of Indian government is to utilise the benefits of technology to render various services to Indian population. Healthcare is one of the segments that have been targeted by these projects.

However, projects like Digital India are suffering from many shortcomings and this has made the Digital India project vulnerable to judicial interventions. Just like the Supreme Court of India had to interfere in the Aadhaar and section 66A cases, the Supreme Court of India may also have to interfere with the implementation of Digital India project.

This is because the digital India project is not supported by a well drafted and analysed plan and policy decision of Indian government. Further, Digital India is also relying upon illegal and problematic platforms and technology like Aadhaar itself that makes the Digital India project itself vulnerable to judicial attacks.

So from the present position one can easily deduce that there is no correlation and synergy between Digital India and the healthcare initiatives of Indian government. The healthcare laws of India are simply outdated, irrelevant and ill suited to meet the objective of Digital India. Fields like e-health, m-health, telemedicine, etc require dedicated techno legal framework that is missing in India. As a result, healthcare industry and healthcare entrepreneurs of India are presently acting more on the side of violation than compliances.

At Perry4Law we strongly recommend that online pharmacies must be suitably regulated in India for the larger benefit of Indian population. So bad is the situation that many online pharmacies in India are controlled by underworld and organised criminal networks. It is very important to sort out illegal online pharmacies from those that are operating within the parameters of Indian laws.

Similarly, online pharmacies operating in India must conduct a proper cyber law due diligence (PDF) exercise to make it sure that they are on the right side of the law. As on date most of the online pharmacies operating form India are not complying with the techno legal requirement as prescribed by Indian laws. It is for Indian government to punish such illegal online pharmacies so that health hazards can be prevented at the earliest stages.

Resolve E-Commerce Disputes In India Through ODR

Resolve E-Commerce Disputes In India Through ODRE-commerce has introduced significant choices for Indian consumers and customers. However, e-commerce in India has also given rise to many disputes by the consumers purchasing the products from e-commerce websites.

There is no formal e-commerce dispute resolution regulatory mechanism in India as we have no dedicated e-commerce laws in India. In fact, many e-commerce websites are not following Indian laws at all and they are also not very fair while dealing with their consumers. Allegations of predatory pricing, tax avoidance, anti competitive practices, etc have been leveled against big e-commerce players of India.

As a result, disputes are common in India that are not satisfactorily redressed. This reduces the confidence in the e-commerce segment and the unsatisfied consumers have little choice against the big e-commerce players. At a time when we are moving toward global norms for e-commerce business activities, the present e-commerce environment of India needs fine tuning and regulatory scrutiny. In fact, India is exploring the possibility of regulation of e-commerce through either Telecom Regulatory Authority of India (TRAI) or through different Ministries/Departments of Central Government in a collective manner.

It is obvious that e-commerce related issues are not easy to manage. E-commerce disputes resolution is even more difficult and challenging especially when Indian Courts are already overburdened with court cases. Of course, establishment of e-courts in India and use of online dispute resolution (ODR) in India are very viable and convincing options before the Indian Government.

To make ODR a success in India, Techno Legal Centre of Excellence for Online Dispute Resolution (ODR) in India (TLCEODRI) has been providing its techno legal ODR services to national and international stakeholders. TLCEODRI has now decided to manage e-commerce disputes resolution in India through its techno legal ODR platform. To implement this initiative in a smooth manner, an ODR Discussion Forum has been started by TLCEODRI.

We have also started a dedicated Board/Thread at the ODR Discussion Forum for E-Commerce Dispute resolution In India through ODR (registration required). This is a good opportunity for e-commerce websites of India and abroad to get good techno legal insight about Indian laws and their implementation to e-commerce field.

The access and registration to this Board is allowed to e-commerce websites alone that have already been established and are operating in India. Our existing e-commerce clients and other clients can contact us for immediate activation of their accounts while the registration request of other e-commerce websites would be duly approved/disapproved by our moderators/administrators.  If an e-commerce websites is engaging us for our techno legal services, it would be granted immediate access to this segment at its request.

Very soon we would introduce additional features for e-commerce companies and online consumers. This would also include online filing of complaints and grievance by the consumers and other aggrieved individuals/companies against the e-commerce companies of India and abroad. Such complaints and grievances would be openly available for public access to general public, regulatory authorities and other e-commerce stakeholders.

We would also introduce a system where grievance can be managed by the e-commerce companies/websites and their consumers through multiple dispute resolution processes and stages of TLCEODRI. This would include conciliation, mediation and arbitration through ODR mechanisms. Please check our ODR Discussion Forum for regular updates about the ODR services of TLCEODRI.

Will TRAI Regulate E-Commerce In India?

Will TRAI Regulate E-Commerce In IndiaE-commerce has really flourished in India but there is no dedicated e-commerce law in India till date. We at Perry4Law Organisation (P4LO) believe that e-commerce laws in India are urgently needed. We also recommended that India should regulate taxation, anti competitive practices and predatory pricing of Indian and foreign e-commerce websites. We have also discussed about cyber security issues of e-commerce business in India.

Meanwhile, United States is seeking trade rules at WTO for e-commerce and cloud computing. There are also some hints that foreign companies and e-commerce portals would be required to register in India and comply with Indian laws.

Many Indian stakeholders have raised objections about the way e-commerce websites are operating in India. These websites are providing deep discounts that have been labelled as predatory pricing by offline traders and businesses. Further, Myntra, Flipkart, Amazon, Uber, etc have already been questioned by the regulatory authorities of India for violating Indian laws.

A techno legal framework is long due and Indian Government has failed to provide the same so far. There is no doubt that e-commerce websites must be suitably regulated by Indian Government. However, the question is who would regulate and monitor e-commerce activities in India?

According to Business Standard, an inter-ministerial panel has requested the Telecom Regulatory Authority of India (TRAI) to take up the role of e-commerce regulator in India or suggest if there is a need for a separate regulator for e-commerce. At present, TRAI regulates telecommunications, media and broadcasting industries.

The inter-ministerial panel will prepare a paper on imposing restrictions on the location of servers and on getting companies like Google and Amazon to set up data centres in India. Similarly, Internet telephony and VOIP service providers are already under pressure to establish their servers in India. The telecom related trends and development in India 2014 by P4LO have also outlines server location related issues for India.

The panel has also sought an update from the consumer affairs ministry on measures taken to introduce online dispute resolution in e-commerce. P4LO has been recommending use of online dispute resolution (ODR) in India for long. ODR can be used for resolving corporate disputes, certain civil disputes, e-commerce disputes, cross border technology transactions disputes, cross border business disputes, etc.

US Seeks Trade Rules At WTO For E-Commerce And Cloud Computing

US Seeks Trade Rules At WTO For E-Commerce And Cloud ComputingThe General Agreement on Trade in Services (GATS) may be discussed once again at the World Trade Organization (WTO) level. This is partly due to the fact that information and communication technology (ICT) has changed the way services are delivered today in a cross border environment. This is also due to the reason that United States (U.S.) is planning to use the WTO platform for securing strong trade rules for the electronic commerce and cloud computing industry. Both of these industries are dominantly controlled by U.S. based companies and this would definitely help U.S and its technology companies.

This proposition of U.S. is troublesome and not acceptable to many nations of the world. Even India would not be happy with this arrangement especially at a time when India is reviving her electronic industry.

India has already justified its preferential market access (PMA) policy for domestic telecom equipments manufacturers. India has also formulated the merger and acquisitions (M&A) policy and guidelines 2014 for telecom sector of India. Similarly, electronic system design and manufacturing (ESDM) policy and regulations in India 2014 have also been enacted by India.

On the other hand, U.S. is planning to spearhead a robust work programme to frame trade rules to allow cross-border information flows, remove localization requirements for protecting personal data within national borders, and agree to a proper coverage of cloud computing as part of computer and related services. Regulations in some countries consider cloud computing as a telecommunications service and U.S. is anxious to get a reversal notification on this issue.

U.S. is already negotiating about these fields at Trans-Pacific Partnership (TPP) regional trade liberalization talks and Trade in Services Agreement (TISA) talks with selective countries in Geneva. However, nothing can give U.S. more leverage than a binding international treaty of WTO in this regard as almost all of the countries are Member of WTO. This also means that countries like China, India, Brazil, South Africa, Indonesia and other developing countries would be forced to align their respective laws in terms of proposed agreement.

In a restricted proposal circulated at the WTO’s Council for Trade in Services last Thursday, the U.S. has expressed its intentions to facilitate e-commerce, an area in which WTO members have remained unsuccessful in arriving at an agreement since 1998. The U.S. wants complete freedom for cross-border information flows. It says “governments should not prevent services suppliers of other countries or customers of those suppliers, from electronically transferring information internally or across borders, accessing publicly available information, or accessing their own information stored in other countries”.

More importantly, governments should not insist that “ICT service suppliers use local infrastructure, or establish a local presence, as a condition of supplying services”. Further, governments must not give priority or preferential treatment to national suppliers of ICT services in the use of local infrastructure, national spectrum or orbital resources. As far as India is concerned, all these issue are bound to be agitated against and rejected by her as they are in conflict with existing policies of India in this regard.

We at Perry4Law and Perry4Law’s Techno Legal Base (PTLB) believe that this proposal of U.S. must also to be tested on the front of civil liberties protection in cyberspace, privacy and data protection (PDF), conflict of laws in cyberspace and many more techno legal issues as well.

E-Books Laws In India

E-Books Laws In IndiaThe Digital India project by Indian government has short listed areas like education, judiciary, healthcare, etc to be taken up for development and implementation. All these fields would be strengthened by using information and communication technologies (ICT) for effective and transparent delivery of public services in India.  For instance, India would strengthen and rejuvenate Indian Judiciary by trying to establish e-courts under the Digital India project. Unfortunately, the e-courts project of India has recently face a major setback when the e-committee refused to record proceeding in courts in electronic manner.

On the positive side, the e-books project of Indian government under the Digital India project has shown some affirmative developments. Digitisation of books is also undergoing in some of the libraries of India. We have a national digital preservation policy of India that can be helpful in the digitisation drive in general and digital preservation in India in particular.

However, while performing the digitisation of traditional books and other academic materials, Indian government must keep in mind the legal mandates of Public records Act, 1993 and Information Technology Act, 2000. Similarly, there are certain legal requirements while converting, selling, distributing, uploading and making available e-books to the end users. This is more so where international users are involved as that would require compliance with laws of multiple jurisdictions.

Needless to mention, e-commerce laws of India would also be required to be followed by various stakeholders where commercial interests are involved. For instance, if an e-commerce website is selling e-books to international end users there are complicated set of laws that are applicable in such circumstances.

Further, conflict of laws in cyberspace has added its own set of problems while dealing with e-books at international and national levels. Intellectual property rights protection at the international level is really tedious when Internet and cyberspace is involved. Even a simple demand for basic electronic details of the accused offender may take months to materialise when foreign technology companies are involved.

In the international market, regulations of and litigation in the field of books publication and e-books are fast increasing. For instance, Apple was fined in Beijing court for unauthorised e-books sale. Similarly, publishers entered into a settlement with European Union for e-books price fixation. The Penguin Group also settled an e-book price escalation lawsuit recently. Amazon has also settled its dispute with Hachette recently involving e-books.

As far as India is concerned, e-commerce players like Amazon, Flipkart, etc are already engaged in selling of e-books in India. However, predatory pricing and taxation issues are still not clear in India. In fact, the Federation of Publishers’ and Booksellers’ Associations in India (FPBAI) has questioned the predatory pricing tactics adopted by Indian e-commerce players selling the books. There would be much more disputes and controversies when e-books would be involved as there is no settled law in India in this regard.

There is also great chances that the terms and conditions and other legal documents of various e-commerce players are not drafted as per Indian laws and this would create legal problems to parties dealing with the website.  In some cases these legal documents may be drafted in an anti competitive manner and may also be detrimental to the interests of the consumers. Indian government is planning to amend the consumer protection law of India to protect consumers’ rights in the e-commerce era.

At Perry4Law we have been dealing with publishing industry related legal issues in general and e-books related international and national legal issues in particular. From our experience we can just say that conversion and selling of e-books is not an easy task and these activities require techno legal compliances on the part of various stakeholders, including Indian government.

FPBAI Questions The Predatory Pricing Tactics Of E-Commerce Websites Of India

FPBAI Questions The Predatory Pricing Tactics Of E-Commerce Websites Of IndiaThe books publication industry of India is passing through a crucial and highly competitive phase. The growing popularity of e-books and sale of paper books at e-commerce websites have changed the way books were published, distributed and sold in India so far.

In the international market, regulations of and litigation in the field of books publication and e-books are fast increasing. For instance, Apple was fined in Beijing court for unauthorised e-books sale. Similarly, publishers entered into a settlement with European Union for e-books price fixation. The Penguin Group also settled an e-book price escalation lawsuit recently.

Back in India, the books distribution and wholesale channels have been severely hit by the burgeoning e-commerce business of India. While healthy competition is always welcome and is good or the consumers yet unreasonable and unethical business practices must be curbed at the very inception.

Unfortunately, Indian e-commerce websites are operating in an unregulated manner and they need to be suitably regulated as soon as possible. E-commerce websites in India are also engaging in violation of various Indian laws including taxation laws, foreign exchange laws, consumer laws and contractual laws. E-commerce websites in India are also engaging in predatory pricing thereby pushing the small business houses and businessmen out of business.

Books publishers in India have now decided to seek policy as well as legal intervention against the predatory pricing tactics of Indian e-commerce websites. The Federation of Publishers’ and Booksellers’ Associations in India (FPBAI) had recently written to Prime Minister Narendra Modi and the Ministries of Finance, Commerce, and Human Resource Development, complaining about the “questionable trade practices” adopted by e-commerce websites like Flipkart and Amazon. In fact, Myntra, Flipkart, Amazon, Uber, etc have already been questioned by the regulatory authorities of India for violating Indian laws.

S. Chand, a well-known publisher of text books, had also served a legal notice to Flipkart six months ago, accusing it of modifying discount structures, violating the clause, and retailing only their fast-selling titles. S. Chand has also snapped all ties with Flipkart and stopped providing its books to FlipKart since then. However, Flipkart continues to sell S. Chand’s books by sourcing them from wholesalers.

The FPBAI letter also seeks action to protect the publishing trade. E-commerce websites are purchasing books at lower discounts from publishers and distributors and sell the same at higher discounts, making a loss in each transaction. It is indeed a questionable activity as it smacks of the act of predatory pricing. In fact, bookstores such as Capital Book Depot in Chandigarh, Teksons and New Book Depot in Delhi have already shut their shops and many others are struggling for survival due to predatory pricing activities of e-commerce websites in India.

There is an urgent need on the part of Indian government to step in and come out with a dedicated e-commerce law of India to regulate the e-commerce activities in best possible manner. A techno legal framework is long due and Indian government has failed to provide the same so far.

India Should Regulate Taxation, Anti Competitive Practices And Predatory Pricing Of Indian And Foreign E-Commerce Websites

India Should Regulate Taxation, Anti Competitive Practices And Predatory Pricing Of Indian And Foreign E-Commerce WebsitesE-commerce in India has been in news for both good and bad reasons. It is really good to know that Indian e-commerce players have started making their own mark in the e-commerce sphere. However, it is equally alarming that e-commerce websites of India are not following the e-commerce laws of India. As a result e-commerce frauds in India have significantly increased and there is an urgent need to regulate and punish such e-commerce offences and crimes in India.

In fact, Myntra, Flipkart and many more e-commerce websites are under regulatory scanner of Enforcement Directorate (ED) of India for violating Indian laws and policies. ED has also raided two Bitcoins websites and their offices. ED believes that Bitcoins money can be used for hawala transactions and funding terror operations and this seems to be a legally plausible explanation as well.

E-commerce websites and technology companies are also under the scanner of taxation and regulatory authorities around the world. For instance, some believe that Amazon, Google and Starbucks are playing with the U.K. tax laws. Similarly, foreign companies and e-commerce portals would be required to register in India and comply with Indian laws. Indian government has also proposed establishment of Income Tax Overseas Units (ITOUs) of India in foreign countries to deal with evasion of taxes.

Transfer pricing issues have become a bone of contention for multi national corporations (MNCs) operating in India. Vodafone, Nokia and Shell have already received notices from income tax authorities of India regarding transfer pricing and other taxation issues. There are also great chances that the compulsory transfer pricing audit based on monetary threshold may be scrapped in India. Indian Tax Department has already received 232 applications from MNCs in 2013-14 for Advance Pricing Agreement.

However, if we analyse the trends in this regard, companies like Google, Facebook, Samsung etc may face more scrutiny from EU, U.S. and Indian regulators in the future. For instance, Google faced an anti trust suit for abusing its search results that was finally settled by it with the Federal Trade Commission (FTC) of United States. However, the antitrust probe initiated by the European Union (EU) is still pending a resolution.

A case has also been filed before the Competition Commission of India (CCI) against Google in for discriminatory trade practices related to its AdWords program. It has been alleged by the complainant that Google has abused its dominance by engaging in discriminatory and retaliatory practices relating to AdWords. A similar complaint was also filed by the Consumer Unity and Trust Society (CUTS) against Google before the CCI. The CCI also imposed a fine of Rs. 1 Crore upon Google for failure to supply information/ documents in the investigations. When Google planned to launch its Flight Travel Search Service in India, Indian stakeholders threatened to file a case before the CCI. Google App Vault may also raise regulatory issues if introduced in India without complying with the techno legal requirements.

Small and medium businesses and entrepreneurs of India are also facing the problem of predatory pricing undertaken by big e-commerce websites operating in India. With great financial resources, the e-commerce companies and websites offer products and services that cannot be offered in normal course of business. As a result, the small businesses cannot sell their products in the market and they are forced to quit the market. This now leaves only the big fishes to explore and monopolise the Indian market.

We at Perry4Law believe that there is an urgent need on the part of Indian government to look into this unfair practice commonly adopted by e-commerce websites in India. These practices are resulting in e-commerce frauds, violation of Indian laws and disturbing the balance of trade, commerce and business in Indian market. These unproductive, unprofessional, illegal and unethical activities cannot be allowed to operate in India anymore.

NPPA Issues Order For All Pharmaceutical Manufacturers And Firms To Register Under The Integrated Pharmaceutical Database Management System (IPDSM) Of India

NPPA Issues Order For All Pharmaceutical Manufacturers And Firms To Register Under The Integrated Pharmaceutical Database Management System (IPDSM) Of IndiaThe National Pharmaceutical Pricing Authority (NPPA) of India has been assigned the task of implementing the National Pharmaceutical Pricing Policy (NPPP), 2012 and the Drugs (Prices Control) Order 2013 (DPCO 2013). As an authority to manage and regulate these issues, NPPA is required to take all necessary measures for smooth and efficient implementation of the NPPP, 2012 and the DPCO, 2013.

Information technology has also introduced both challenges and opportunities for pharmaceutical stakeholders of India. Indian government has recently announced formulation of Electronic Health Record (EHR) Standards of India. AIIMS Bhubaneswar has also announced that it will launch Electronic Health Card for its patients. AIIMS, Delhi has introduced a system where patients can fix appointments with doctors over phone.

However, regulatory issues in these regard have been ignored by various healthcare stakeholders in India. For instance, online sale and purchase of prescribed drugs and medicines in India is happening in an unregulated manner. There are specific laws and regulatory requirements for opening of online pharmacies in India. But almost all of the online pharmacies are not following various laws of India applicable in this regard.

Although a full fledged action against illegal online pharmacies of India is still awaited yet the NPPA has issued a Notice to all pharmaceutical manufacturers to register themselves under the Integrated Pharmaceutical Database Management System (IPDSM) for online filing of returns in Form II, III, and V under DPCO, 2013. The term “manufacturers” for the purpose of this Notice/Order means any person who manufactures, imports and markets drugs for distribution or sale in the country.

Besides online filing of returns, the IPDSM would also ensure monitoring, fixing and revision of drug prices in India. The registration process is compulsory in nature and it will be open upto 31st October 2014 after which that data inputting facility shall be made available to all registered users for submission of online reports in respect of form II, III and V under DPCO 2013.

According to NPPA availability of reliable database is a necessary pre-requisite for carrying out the functions of price fixation and price revision in respect scheduled drugs; price fixation in respect of new drugs; monitoring the production and availability of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulations; and monitoring the prices of non-scheduled formulations.

This reporting obligation on the part of pharmaceutical manufacturers is a legal obligation, which they are required to carry out with full and correct disclosure of information in a timely manner at prescribed intervals. Any default in the reporting would be deemed to be an act of contravention of the DPCO 2013 and therefore attracts penalties under the Essential Commodities Act, 1955.

Supreme Court Stays Bombay High Court Judgment That Quashed Product Advisory Issued By FSSAI

Supreme Court Stays Bombay High Court Judgment That Quashed Product Advisory Issued By FSSAIRecently the Bombay High Court stayed the scheme of product approval by Food Safety and Standards Authority of India (FSSAI) for six months after considering it as ambiguous. This created great inconvenience to FSSAI and dietary supplement, health supplement, functional food and nutraceutical industry of India. Obviously, the decision of Bombay High Court was challenged before the Supreme Court of India.

Now the Supreme Court of India has stayed the Bombay High Court judgment. A bench headed by Justice JS Khehar stayed the HC decision after FSSAI alleged that the impugned order has paralysed the mechanism to enforce food safety norms on imported food items.

The impugned product approval scheme by FSSAI initially limited the requirement of product approval for novel foods that contain ingredients which are introduced for the first time in the country or which do not have a history of safe use. However, the scope of scheme was extended to cover all categories of products which are not standardised, even if they were old and established in the market.

The HC held that the advisory to manufacturers had no force of law and FSSAI had no power to issue the impugned communication without it being ratified by the two houses of Parliament. “The order has also had the effect of paralysing almost entirely the discharge of regulatory functions by the Food Authority in relation to all the food products that are specified under Section 22 of the Act,” Solicitor-General Ranjit Kumar said.