Drug Advisory Council and Drug Advisory Committee Formation Regulations, 2037

What does it do?

• For Section 3 of the Drugs Act, 2035, the regulation sets up a Drug Consultative Council. As printed, it is chaired by the Minister or State Minister for Forest, with a National Planning Commission member as vice-chair. Members include the secretaries of the forest, finance, health and industry and commerce ministries and three people with knowledge of medicines nominated by the government for three years. The manager of the Department of Drug Administration is member-secretary.औषधि ऐन, २०३५ को दफा ३ को प्रयोजनका लागि यस नियमावलीले औषधि परामर्श परिषद् गठन गरेको छ। छापिएबमोजिम यसको अध्यक्ष वन मन्त्री वा वन राज्यमन्त्री र उपाध्यक्ष राष्ट्रिय योजना आयोगका सदस्य हुन्छन्। वन, अर्थ, स्वास्थ्य र उद्योग तथा वाणिज्य मन्त्रालयका सचिव तथा औषधिसम्बन्धी ज्ञान भएका नेपाल सरकारले तीन वर्षका लागि मनोनीत गरेका तीन जना सदस्य हुन्छन्। औषधि व्यवस्था विभागका व्यवस्थापक सदस्य-सचिव हुन्छन्। Nepal Law Commission Rule 3(1)-(2), PDF pp. 1-2
• The Council must advise the government on policy and administrative matters about medicines. Its main aims are to protect the national interest, reduce production that depends on imports, and make the country self-reliant by relying more on its own medicinal herbs. It may also advise on drug prices, patents, banning the production, sale, storage or transport of a drug, recognising laboratories, and complaints about medicines.परिषद्ले औषधिसम्बन्धी नीतिगत र प्रशासनिक विषयमा नेपाल सरकारलाई परामर्श दिनुपर्छ। राष्ट्रिय हित संरक्षण गर्ने, पैठारीमा आधारित उत्पादन घटाउने र स्वदेशकै जडीबुटीमा बढी भर पर्दै देशलाई आत्मनिर्भर बनाउने यसको मुख्य उद्देश्य हो। औषधिको मूल्य, पेटेण्ट, कुनै औषधिको उत्पादन, बिक्री, सञ्चय वा ढुवानीमा रोक, प्रयोगशालालाई मान्यता र औषधिसम्बन्धी उजुरीबारे पनि परिषद्ले परामर्श दिन सक्छ। Nepal Law Commission Rule 4(1)-(2), PDF pp. 2-3
• For Section 4 of the Act, a Drug Advisory Committee is chaired by the Secretary of the Ministry of Health and Population, with the Director General of the Department of Health Services as vice-chair. Members include health ministry and department officials and representatives of the drug manufacturers', medical, pharmaceutical and chemists' and druggists' associations. It must advise the Department of Drug Administration on technical matters of drug research, development and control.ऐनको दफा ४ को प्रयोजनका लागि गठित औषधि सल्लाहकार समितिको अध्यक्ष स्वास्थ्य तथा जनसंख्या मन्त्रालयका सचिव र उपाध्यक्ष स्वास्थ्य सेवा विभागका महानिर्देशक हुन्छन्। मन्त्रालय र विभागका अधिकारी तथा औषधि उत्पादक, मेडिकल, फार्मास्युटिकल र केमिष्ट एण्ड ड्रगिष्ट संघका प्रतिनिधि सदस्य हुन्छन्। औषधिको अनुसन्धान, विकास र नियन्त्रणसम्बन्धी प्राविधिक विषयमा समितिले औषधि व्यवस्था विभागलाई परामर्श दिनुपर्छ। Nepal Law Commission Rules 5(1) and 6(1), PDF pp. 3-4
• The Committee may also advise on drug standards and testing methods, preparing a Nepal Pharmacopoeia, and codes on safe production, sale and storage, preventing misuse and misleading advertising, recalling unsafe drugs, and keeping narcotic and poisonous drugs. It may advise on classifying drugs, recognising pharmacists, and setting qualifications for people in the drug business.समितिले औषधिको स्तर र परीक्षण विधि, नेपाल फार्माकोपिया तयार गर्ने काम तथा सुरक्षित उत्पादन, बिक्री वितरण र सञ्चय, दुरुपयोग र भ्रमात्मक विज्ञापन रोक्ने, असुरक्षित औषधि फिर्ता गराउने र लागू तथा विषालु औषधि सुरक्षित राख्नेसम्बन्धी संहिताबारे पनि परामर्श दिन सक्छ। औषधिको वर्गीकरण, फार्मासिष्टलाई मान्यता र व्यवसायीको योग्यता तोक्ने विषयमा पनि यसले परामर्श दिन सक्छ। Nepal Law Commission Rule 6(2)(क)-(छ), PDF pp. 4-5
• Council and Committee meetings need more than half of all members present. Decisions are by majority, with the chair holding a casting vote, and the member-secretary keeps and certifies the decisions. Non-government members receive a meeting allowance set by the government. The Council deals with the government through the Ministry of Forest, and the Department of Drug Administration runs the work of both bodies.परिषद् वा समितिको बैठकमा कुल सदस्य संख्याको आधाभन्दा बढी सदस्य उपस्थित हुनुपर्छ। निर्णय बहुमतबाट हुन्छ र मत बराबर भएमा अध्यक्षता गर्नेले निर्णायक मत दिन्छ। सदस्य-सचिवले निर्णय अभिलेख राखी प्रमाणित गर्छन्। गैरसरकारी सदस्यले नेपाल सरकारले तोकेको बैठक भत्ता पाउँछन्। परिषद्ले वन मन्त्रालयमार्फत नेपाल सरकारसँग सम्पर्क राख्छ र दुवै निकायको काम सञ्चालनको व्यवस्था औषधि व्यवस्था विभागले गर्छ। Nepal Law Commission Rules 7(1)-(6), 8, 9 and 10, PDF pp. 5-6

Gaps, loopholes and improvement ideas

None documented in the official reports we have reviewed so far.

Where does it conflict with other laws?

No conflict with another law is documented in the sources we have reviewed so far.