To facilitate the availability of small quantity of drugs for personal use for the needy patients of India. The procedure has been simplified which as follows:
I. PROVISIONS UNDER DRUGS & COSMETICS RULES
Rule 36 of Drugs & Cosmetics Rule provides Import of drugs for personal use. Small quantities of drugs, the import of which is otherwise prohibited under Section 10 of the Act, may be imported for personal use subject to the following conditions:
(i) the drugs shall form part of a passenger’s bona fide baggage and shall be the property of, and be intended for, the exclusive personal use of the passenger;
(ii) the drugs shall be declared to the Customs authorities if they so direct;
(iii) the quantity of any single drug so imported shall not exceed one hundred average doses:
Provided that the licensing authority may in an exceptional case in any individual case sanctions the import of a large quantity:
Provided further that any drug, imported for personal use but not forming part of bona fide personal baggage, may be allowed to be imported subject to the following conditions, namely:
(i) the licensing authority, on an application made to it in Form 12-A is satisfied that the drug is for bona fide personal use;
(ii) the quantity to be imported is reasonable in the opinion of the licensing authority and is covered by prescription from a registered medical practitioner ; and
(iii) the licensing authority grants a permit in respect of the said drug in Form 12-B.
II. PROCEDURE TO OBTAIN PERMISSION:
- Download the application in FORM 12 A.
- Prescription from Registered Medical Practitioner (RMP) in respect of the drug requirements for the purpose of patient use required to be attached. Prescription shall bear Medical Council of India (MCI) Registration No. of the Physician.
- Fill and sign the application in Form 12A alongwith the Prescription and submit to ADC(I)/TO/DI of the respective port offices of Central Drugs Standard Control Organization (CDSCO). The list of such offices is at Annexure A
- No fee is required under the Rule for said purpose.
- The name of the drug, quantity of the drug and duration of medication shall be clearly mentioned in the Prescription.
- Permission in FORM 12 B shall be issued to applicant on priority basis preferably in a day or two.
III In case of delay or further clarification, following officer are designated at the Secretariat of DCG (I), CDSCO (HQ), FDA Bhawan, Kotla Road, New Delhi. 110002
1. Mr. Aseem Sahu, Deputy Drugs Controller (I)
2. Dr. V. Kasi Sankar, Drugs Inspector
Ph. No.: 011-23236965; Fax. No.: 011-23236973, Email id : firstname.lastname@example.org
India was once recognized as the world’s epicentre of polio. But there has not been a single recorded case of polio in India since 13 Jan 2011. If all pending laboratory investigations return negative, in the coming weeks India will officially be deemed to have stopped indigenous transmission of wild poliovirus.
“India’s success is arguably its greatest public health achievement and has provided a global opportunity to push for the end of polio,” said WHO Director-General Margaret Chan. “The Global Polio Eradication Initiative is in full emergency mode and focused on using this momentum to close this crippling disease down. Stopping polio in India required creativity, perseverance and professionalism – many of the innovations in polio eradication were sparked by the challenges in India. The lessons from India must now be adapted and implemented through emergency actions to finish polio everywhere.”
The key to India’s remarkable progress in the fight against polio according to UNICEF Executive Director Anthony Lake, has been the strong leadership of the Government of India and state governments, which launched a comprehensive polio eradication programme that has enabled sustained high immunization coverage in states like Uttar Pradesh and Bihar with high rates of poverty, high population density and poor sanitation and infrastructure, conditions in which disease like polio can thrive.
“India’s achievement is proof positive that we can eradicate polio even in the most challenging environments – in fact, it is only by targeting these areas that we can defeat this evil disease,” Mr Lake said. “We have the ability to protect every last person, especially children, from this entirely preventable disease – and because we can, we must finish the job of eradicating polio globally, once and for all.”
When all pending specimens are processed (stools from children with acute flaccid paralysis and samples from sewage sampling), if no wild poliovirus is detected, India will no longer be considered polio-endemic. The laboratory system is expected to clear all samples within 4–6 weeks of collection.
The Global Polio Eradication Initiative (GPEI) is spearheaded by national governments, WHO, Rotary International, the US Centers for Disease Control and Prevention (CDC) and UNICEF.
Pictures Courtesy : UNICEF
Schedule D under D&C Rules to be amended to stop practice of import of APIs for further purification without registration
The Centre will soon amend the Schedule D of the Drugs and Cosmetic Rules to stop the practice of importing active pharmaceutical ingredients for further purification without following the process of registration and import license.
The move is initiated following the reports that many importers were importing bulk drug or APIs as Crude Drug or Feed Grade etc. for further purification. Such crude and feed grade drugs are nothing but impure or not of standard quality drugs imported from unregistered, non-GMP sources.
This type of drugs “which are produced at unregistered, non-GMP sources”, if imported by means of bypassing registration procedure under misleading names like Crude and Feed Grade and then by minor purification are sold for use in drug formulations cannot be considered safe for use and can put patient at risk, it was pointed.
The CDSCO had already pointed out this practice in the Guidance Document for Zonal & Port Offices, clearly stating that “the import of drug under dual use for purification or rendering it sterile will not be considered under dual use.” The international guidelines caution against exclusion of drug molecules imported for further purification from registration requirement.
As per this, the Schedule D (relating to substances not intended for medicinal use) will be modified by inserting a new clause: “the exemption excludes drugs imported for further purification only”.
The proposal in this regard was placed recently at the Drugs Consultative Committee (DCC) which agreed for the amendment. “The members agreed that the exemption provided under Schedule D should not be used for bypassing registration procedure and import of crude and feed grade drugs which could be sold as drugs after minor purification etc. The DCC therefore recommended Schedule D may be suitably amended to exclude drugs imported as non-drug items for purely purification and marketing as drugs,” DCC said.
Another welcome move from CDSCO, about the approval of Bioanalytical laboratory that are involved in the conduct of BA/BE studies. Such stringent moves from the office of DCGI will allow a more comprehensive streamlined clinical research process in the BA/BE study set up.
The Planning Commission will soon create a central fund that would be operated only to compensate clinical trial participants in the event of injury during the course of a human study.
The creation of such a fund is seen to be a major support for the clinical research industry. It is a positive move in the right direction as the government has now turned around to recognize the need to chip in financial assistance for patient compensation, Prof. Ranjit Roy Chaudhury, chairman of expert committee on clinical trials told Pharmabiz on the sidelines of the 7th ISCR annual conference.
The funds will not cover any compensation coming under academic research and pharma related drug development activities. It will only be provided to human studies which have been approved by the Technical Review Committee (TRC) constituted under Directorate General of Health Services and therefore it does not dilute the focus of compensation.
“The quantum of funds is not known but definitely it is not a prohibitive allocation for the Planning Commission to set aside. Now we have to ensure that the process of compensating the participants during a trial is implemented properly,” he added.
The need to compensate clinical trials participants will only see them to agree in participating in human studies. Moreover, they would also be assured that in case of an injury, their medical needs would be taken care over and above a compensation. In fact, JIPMER in Pondicherry and the Institute of Liver and Biliary Sciences, New Delhi have begun to compensate its doctors in hospitals if they were injured with surgical and injectable instruments but not patients for clinical trials. Therefore, the funding coming in from the Planning Commission for patients’ compensation costs is seen to be an encouraging start in India’s clinical research regulation, said Prof. Roy.
Further, Prof. Roy was certain that by the end of 2014, the clinical research regulations could be enforced in total. “The formation of the ethics committee was a simple process but the accreditation of sites was seen to take some time. This is where state regulatory authorities need to be associated to audit facilities in their region,” he noted.
Use of information technology and legal framework were the crux of the recommendations which needed considerable coordination, said Prof. Roy adding that the country was facing the challenges of high cost of treatment and poor access to drugs.
“The clinical trial component of the healthcare industry was down on its knees and this is where transparency in human studies is seen to be much wanted. The current scene indicated dismay for clinical research industry. The clinical research organizations are closing down and the reality is that drug research is going away from India. All this has happened because of poor confidence on the sector. Since the government gave a free hand to formulate the recommendations which is now being put in place, the future is hopeful if the sector works to get its house in order and get on to provide credibility in quality research and adhere to ethical practices,” said Prof. Roy.
This is where the concept of ‘Health India’ comes into force, said Prof. Roy adding that drug research should become a national priority.