Clinical Establishments Bill, 2010 passed in the Lok Sabha making it mandatory for all clinical establishments in the country to register as per the provisions of the new statute. The Bill, which has been pending for several years, aims to bring in uniformity in the healthcare delivery and prescribes penalty for the defaulting establishments. The legislation is now applicable to clinical establishments under all recognized systems of medicines or treatment under Allopathy and Ayush. It would apply to all the hospitals or clinics including single doctor establishments, with or without beds. The Act includes any laboratory, which offers pathological, bacteriological, genetic, radiological, chemical, biological and other diagnostic or investigative services. The government or a department of the government, a trust (public or private), a corporation (including a cooperative society), a local authority or a single doctor establishment can own the establishments.

A significant aspect of the new legislation is that it makes it obligatory for any doctor in a registered clinic, hospital or other clinical establishment to provide treatment to anyone who is brought in an emergency medical condition. No patient can be sent back on some reasons. The Act mandates every state to set up a multi-member State Council of Clinical Establishments without delay. The new Act requires that creation of a Registering Authority for Clinical Establishments in each state with a multi-member body at district level. The registration would be of two types, provisional and permanent. Permanent Registration would be provided after standards have been notified. There are different standards for different categories of clinical establishments.

It is rather strange that a country like India did not have a law to regulate clinical establishments for such a long time allowing them to operate without any laid down standards or ethics. Most of them have been following no good medical practices on their own and have been indulging in fraud and undesirable activities. One of the main culprits in this area used to be thousands of pathology laboratories spread across the country. Many a time incorrect assessment of the medical condition by these labs has been responsible for wrong prescription of medicines to the patients. Currently, health departments of most of the state governments do not have a system to check or monitor the activities of path labs or any other diagnostic centres.

As public health is largely a state subject, the Central health ministry has been rather passive in a framing a law to regulate these clinics, hospitals and laboratories. All these are going to change now with this new enactment. The legislation is expected to empower the state government or Registering Authority to direct any or all clinical establishments to furnish such returns/statistics or other information whenever required. Now the question is how soon this law is going to be enforced by the state governments. The ball is in their court. To pass on the benefit of the new law to the public, the state governments have to establish the necessary infrastructure and create a team regulatory staff in right earnest.

The Director General of Foreign Trade (DGFT) has once again amended the Project Authority Certificate (PAC), i.e., Appendix 27 of the Handbook of Procedures, Vol. 1 (HB-1) and the Payment Certificate (PC) i.e., Appendix 22-C of HB-1. It is a useful amendment that resolves the difficulties of deemed exporters to some extent but even after this amendment to the prescribed formats, certain other problems of the deemed exporters continue.

According to the Foreign Trade Policy (FTP), till January, benefits of deemed exports were available to certain categories of deemed exports, only if the supplies of goods were made under the procedure of International Competitive Bidding (ICB). On January 14, Para 8.2 of FTP was amended, allowing deemed export benefits for supplies to mega power projects even without ICB but if the requisite quantum of power had been tied up through tariff-based competitive bidding or if the project had been awarded through tariff-based competitive bidding. Para 8.4.4 of the FTP was also suitably amended.

However, while giving effect to the policy change by amending the PAC and PC, DGFT replaced the clause that related to deemed export supplies to non-mega power projects and refineries. As a result, there was no clause in PAC or PC covering deemed export supplies to non-mega power projects and refineries covered under Para 8.2 (g) of the FTP. The latest amendment rectifies this defect.

By default, the PAC requires the Project Authority to mention the import content of the order in the certificate. This is a legacy of the licensing raj days, when release of foreign exchange was being rationed. It has very little relevance now but it does have a certain nuisance value. For example, at the time of making the contract, the main contractor may envisage no import content but the sub-contractor may have certain requirements later either due to unavailability or unsuitability of the indigenous supplies. In such cases, getting the PAC issued in favour of the sub-contractor showing any import content could pose problems. The best course for the DGFT is to delete all references to the import content in the PAC.

PAC is a document required by main contractors or sub-contractors to obtain advance authorisation to enable duty-free import of inputs required for manufacture of the final products to be supplied as deemed exports for some projects. This is also widely used while claiming excise exemption to satisfy the excise authorities that the supplies are being made to projects or purposes for which zero-duty import is allowed, because the excise law prescribes no documentation to establish that point. If the DGFT can take note of requirements under various laws and so word the PAC format that the requirements under other laws are also satisfied, much unnecessary hardship can be alleviated for deemed exporters at the ground level.

The latest DGFT Public notice dated May 25 also amends the Appendix-13 of HB-1. Earlier, in the list of agencies/funds notified by the finance ministry for the purpose of deemed export benefits, "Yen credit channelised through Japan Bank for International Co-operation (development component only)" was mentioned. Now, the channelising agency is the "Japan International Cooperation Agency".

The Union Cabinet approved the setting up of the Pharmacopoeia Commission for Indian Medicine (PCIM) as an autonomous Society under the Societies Registration Act.

It also approved the creation of a post of Director-cum-Member Secretary of the Commission in the scale and Grade Pay of Joint Secretary to the Government of India.

The Pharmacopoeia Commission for Indian Medicine (PCIM) will have the following objectives:-

• Publication and revision of the Ayurvedic, Siddha and Unani Pharmacopoeia as well as their formulations and also to develop and publish standards of other plants and natural products relevant to Indian Systems of Medicine.
• Develop standards for quality, identity and purity of raw materials and compound formulations as well as to develop Stanard Operating Procedures (SOPs) for the manufacture of Ayurveda, Siddha and Unani (ASU) drugs.
• Maintain National repository of authentic reference raw materials used in the manufacture of Ayurveda, Siddha and Unani medicines and supply of reference standards to the stakeholders.
• Generate and maintain repository of chemical reference marker compounds/extracts of the plants or other ingredients used in standardizing Ayurveda, Siddha and Unani medicines and supply them to the stakeholders.
• Prepare monographs relating to medicinal plants available in the Local Health Traditions of various communities in the country.
• Ensure furtherance of Chapter IV-A of Drugs and Cosmetic Act and Rules dealing with the quality standards related to ASU Drugs.
• Promote research on quality, safety and efficacy of ASU drugs.
• Create awareness about the quality in ASU drugs and formulations.
• Exchange information and interact with Pharmacopoeia Commissions and other international bodies in order to develop global ASU pharmacopoeial standards.